TICE BCG
TICE BCGBCG LiveFor Intravesical Use
Approved
Approval ID
c9b74876-e665-442b-87ad-b7333bc9a67a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
Merck Sharp & Dohme LLC
DUNS: 118446553
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BACILLUS CALMETTE-GUERIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0052-0602
Application NumberBLA102821
Product Classification
M
Marketing Category
C73585
G
Generic Name
BACILLUS CALMETTE-GUERIN
Product Specifications
Route of AdministrationINTRAVESICAL
Effective DateAugust 30, 2022
FDA Product Classification
INGREDIENTS (8)
BACILLUS CALMETTE-GUERIN SUBSTRAIN TICE LIVE ANTIGENActive
Quantity: 50 mg in 50 mL
Code: 2XQ558L16Z
Classification: ACTIB
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POTASSIUM PHOSPHATE, UNSPECIFIED FORMInactive
Code: B7862WZ632
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMInactive
Code: DE08037SAB
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
FERRIC AMMONIUM CITRATEInactive
Code: UVP74NG1C5
Classification: IACT
ASPARAGINEInactive
Code: 5Z33R5TKO7
Classification: IACT