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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
102821Tice BcgBCG Live351(a)Rx2026-06-01

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