FDA.reportPublic FDA data

TICE BCG

Product NDC
0052-0602
11-digit product format
000520602
Labeler code
0052
Product ID
0052-0602_223f2b2b-87d0-4beb-b00a-16a2b041a5bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
BACILLUS CALMETTE-GUERIN
Dosage form
POWDER, FOR SUSPENSION
Route
INTRAVESICAL
Labeler
Merck Sharp & Dohme LLC
Application
BLA102821
Marketing category
BLA
Marketing start
1990-08-24
Substance
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN
Active strength
50 mg/50mL
Pharmacologic classes
Actively Acquired Immunity [PE], BCG Vaccine [CS], Increased Immunologically Active Molecule Activity [PE], Increased Macrophage Proliferation [PE], Live Attenuated Bacillus Calmette-Guerin Immunotherapy [EPC], Live Attenuated Bacillus Calmette-Guerin Vaccine [EPC], Vaccines, Attenuated [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
TICE BCG
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGEN50 mg/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2XQ558L16ZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
213744Internal RxNorm lookup
1653484Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9b74876-e665-442b-87ad-b7333bc9a67aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0052-0602-01TICE BCG50 mL in 1 VIALPOWDER, FOR SUSPENSION5022
0052-0602-02TICE BCG1 in 1 CARTONPOWDER, FOR SUSPENSION122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0052-0602-01EA - Each0052-060263e94ca0-99ed-48f0-ac75-6c0d1c5416a712018-07-03
0052-0602-02EA - Each0052-060220b6da70-5b8f-4d6c-885f-40f704f85bd612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENACTIVE INGREDIENT2XQ558L16ZTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENACTIVE MOIETY2XQ558L16ZTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
ASPARAGINEINACTIVE INGREDIENT5Z33R5TKO7TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
FERRIC AMMONIUM CITRATEINACTIVE INGREDIENTUVP74NG1C5TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SABTICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4
POTASSIUM PHOSPHATE, UNSPECIFIED FORMINACTIVE INGREDIENTB7862WZ632TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [ORGANON USA INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0052-0602TICE BCG (BACILLUS CALMETTE-GUERIN) POWDER, FOR SUSPENSION [MERCK SHARP & DOHME LLC]20Current NDC, Legacy NDC, 2 package rows20241121_c9b74876-e665-442b-87ad-b7333bc9a67a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TICE BCGBACILLUS CALMETTE-GUERINMerck Sharp & Dohme LLCc9b74876-e665-442b-87ad-b7333bc9a67a2026-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA102821
ndc (product): 0052-0602

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
102821Tice BcgBCG Live351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1653484BCG, Tice strain 50 MG Powder for Intravesical SuspensionPSNc9b74876-e665-442b-87ad-b7333bc9a67a22
213744Tice BCG 50 MG Powder for Intravesical SuspensionPSNc9b74876-e665-442b-87ad-b7333bc9a67a22
213744BCG, live, Tice strain 50 MG Powder for Intravesical Suspension [Tice BCG]SBDc9b74876-e665-442b-87ad-b7333bc9a67a22
1653484BCG, live, Tice strain 50 MG Powder for Intravesical SuspensionSCDc9b74876-e665-442b-87ad-b7333bc9a67a22
213744Tice BCG 50 MG Powder for Intravesical SuspensionSYc9b74876-e665-442b-87ad-b7333bc9a67a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0052-0602-010005206020150 mL in 1 VIAL50 mlHistorical
0052-0602-02000520602021 VIAL in 1 CARTON (0052-0602-02) / 50 mL in 1 VIAL (0052-0602-01) 1 vial1990-08-240000-00-00NoNoCurrent