LABELS · 223f2b2b-87d0-4beb-b00a-16a2b041a5bc

TICE BCG

Open original source → · Download preserved record

Preserved label snapshot, not confirmation of a current approved indication. Approval/withdrawal status must be checked for the exact disease, setting and regimen.

Label effective date: 2026-02-20
Captured: 2026-09-09T23:37:42.544548+00:00
Current indication reconciliation: Not reconciled

Boxed warning in this label

WARNING TICE ® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TICE ® BCG as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections). BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS sections).

Indications and usage: exact source text

INDICATIONS AND USAGE TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. TICE BCG is not indicated for papillary tumors of stages higher than T1.

Full extracted label fields

application numbers

BLA102821

boxed warning exact

WARNING TICE ® BCG contains live, attenuated mycobacteria. Because of the potential risk for transmission, prepare, handle, and dispose of TICE ® BCG as a biohazard material (see PRECAUTIONS and DOSAGE AND ADMINISTRATION sections). BCG infections have been reported in health care workers, primarily from exposures resulting from accidental needle sticks or skin lacerations during the preparation of BCG for administration. Nosocomial infections have been reported in patients receiving parenteral drugs that were prepared in areas in which BCG was reconstituted. BCG is capable of dissemination when administered by the intravesical route, and serious infections, including fatal infections, have been reported in patients receiving intravesical BCG (see WARNINGS , PRECAUTIONS , and ADVERSE REACTIONS sections).

brand names

TICE BCG

current indication status

not_reconciled

dailymed set url

https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c9b74876-e665-442b-87ad-b7333bc9a67a

generic names

BACILLUS CALMETTE-GUERIN

223f2b2b-87d0-4beb-b00a-16a2b041a5bc

indications and usage exact

INDICATIONS AND USAGE TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. TICE BCG is not indicated for papillary tumors of stages higher than T1.

indications and usage tables exact

is original packager

true

manufacturer names

Merck Sharp & Dohme LLC

matched search terms

carcinoma
tumor
tumors

package ndcs

0052-0602-01
0052-0602-02

product ndcs

0052-0602

product types

HUMAN PRESCRIPTION DRUG

recent major changes exact

record type

complete_spl_indications_section_candidate

routes

INTRAVESICAL

rxcuis

213744
1653484

source batch

file

/private/tmp/cancer-full-research/indications/raw/labels-00100.json

meta

disclaimer

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

last updated

2026-09-09

license

https://open.fda.gov/license/

results

limit: 100
skip: 100
total: 830

terms

https://open.fda.gov/terms/

sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

url

source url

https://api.fda.gov/drug/label.json?search=id%3A%22223f2b2b-87d0-4beb-b00a-16a2b041a5bc%22

spl effective date

2026-02-20

spl effective time

20260220

spl set id

c9b74876-e665-442b-87ad-b7333bc9a67a

spl version

substance names

BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN

uniis

2XQ558L16Z

verification flags

oncology_keyword_candidate_not_clinically_classified
spl_text_not_verified_identical_to_latest_approved_label
individual_indications_not_split_or_reconciled
no_matched_approved_submission
application_missing_from_drugsfda_bulk

Drugs@FDA application source records

application number
BLA102821
payload
all indexed label documents
all submission records
application number
BLA102821
approval interpretation
Application linkage and approved submission are not indication-level current approval verification
current indication status
not_reconciled
drugsfda url
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=102821
has approved submission record
false
latest approved submission date
Source null
latest label selection rule
max FDA ApplicationDocsDate, including all ties; posting date is not approval date and latest indexed document may be incomplete
latest posted label documents
official application record
Source null
openfda application present
false
products

Source passages and status connections

Passage classifications are automated and are not treatment recommendations. Connections apply only to their recorded indication scope.

Passage 1 · indication intro context

application numbers

BLA102821

brand names

TICE BCG

classification reasons

explicit_positive_indication_predicate
tumor_or_malignant_hematology_words_in_positive_statement
positive_statement_also_contains_qualification_review_required
incomplete_colon_led_indication_intro

clinical review status

pending

content role

indication_intro_context

context span

end: 463
end exclusive: true
exact text: INDICATIONS AND USAGE TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. TICE BCG is not indicated for papillary tumors of stages higher than T1.
label id: 223f2b2b-87d0-4beb-b00a-16a2b041a5bc
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b7a4324770dc5b27a1d8d1820260c50f386ae537e0dc484890c3e95753b94c73
start: 0

current approval status

not_reconciled

duplicate text group

dup-b59da0a1d252d1f41aef

extraction review status

automated_candidate_pending_source_review

generic names

BACILLUS CALMETTE-GUERIN

ind-span-c47212ad6c3883be647c

label id

223f2b2b-87d0-4beb-b00a-16a2b041a5bc

positive predicate support span

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source text sha256: b7a4324770dc5b27a1d8d1820260c50f386ae537e0dc484890c3e95753b94c73
start: 33

qualifier mentions

context exact
(CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use
kind
stage_or_setting
polarity
not_inferred
span
end
205
end exclusive
true
exact text
recurrent stage Ta and/or T1 papillary tumor
label id
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offset unit
unicode_code_points
source array index
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source field
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source text sha256
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start
161

regulatory links

schema version

0.1.0

source batch sha256

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source defined aliases

source span

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exact text: INDICATIONS AND USAGE TICE ® BCG is indicated for: the treatment and prophylaxis of carcinoma in situ (CIS) of the urinary bladder the prophylaxis of primary or recurrent stage Ta and/or T1 papillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence.
label id: 223f2b2b-87d0-4beb-b00a-16a2b041a5bc
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b7a4324770dc5b27a1d8d1820260c50f386ae537e0dc484890c3e95753b94c73
start: 0

source url

https://api.fda.gov/drug/label.json?search=id%3A%22223f2b2b-87d0-4beb-b00a-16a2b041a5bc%22

spl effective date

2026-02-20

spl set id

c9b74876-e665-442b-87ad-b7333bc9a67a

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Passage 2 · limitation of use

application numbers

BLA102821

brand names

TICE BCG

classification reasons

negative_or_not_established_clause

clinical review status

pending

content role

limitation_of_use

context span

end: 463
end exclusive: true
exact text: apillary tumors following transurethral resection (TUR) Limitations of Use: TICE BCG is not recommended for stage TaG1 papillary tumors, unless they are judged to be at high risk of tumor recurrence. TICE BCG is not indicated for papillary tumors of stages higher than T1.
label id: 223f2b2b-87d0-4beb-b00a-16a2b041a5bc
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b7a4324770dc5b27a1d8d1820260c50f386ae537e0dc484890c3e95753b94c73
start: 191

current approval status

not_reconciled

duplicate text group

dup-9c917d2663a08f563b4a

extraction review status

automated_candidate_pending_source_review

generic names

BACILLUS CALMETTE-GUERIN

ind-span-b72434cf2a601c5c6087

label id

223f2b2b-87d0-4beb-b00a-16a2b041a5bc

positive predicate support span

Source null

qualifier mentions

regulatory links

schema version

0.1.0

source batch sha256

fc39a8c5cf96bf95ca20b85578140167b66b2741f7d9217f500d9ba0847ac058

source defined aliases

source span

end: 463
end exclusive: true
exact text: TICE BCG is not indicated for papillary tumors of stages higher than T1.
label id: 223f2b2b-87d0-4beb-b00a-16a2b041a5bc
offset unit: unicode_code_points
source array index: 0
source field: indications_and_usage_exact
source text sha256: b7a4324770dc5b27a1d8d1820260c50f386ae537e0dc484890c3e95753b94c73
start: 391

source url

https://api.fda.gov/drug/label.json?search=id%3A%22223f2b2b-87d0-4beb-b00a-16a2b041a5bc%22

spl effective date

2026-02-20

spl set id

c9b74876-e665-442b-87ad-b7333bc9a67a

spl version

structured fields status

not_extracted_no_values_inferred_from_mentions

structured indication

age: Source null
approval pathway: Source null
biomarker and test: Source null
disease stage: Source null
limitations: Source null
line: Source null
prior therapy: Source null
regimen: Source null
tumor histology: Source null

use intent

not_applicable

Preserved source evidence · Not medical advice