Pentazocine Hydrochloride and Acetaminophen
Pentazocine Hydrochloride and Acetaminophen Tablets
Approved
Approval ID
62a055f3-a58b-446d-9476-af6d36956eaf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 12, 2011
Manufacturers
FDA
GAVIS Pharmaceuticals, LLC
DUNS: 829838551
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pentazocine Hydrochloride and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43386-670
Application NumberANDA076202
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pentazocine Hydrochloride and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJuly 12, 2011
FDA Product Classification
INGREDIENTS (8)
PENTAZOCINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: A36BXO4PPX
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT