Pentazocine and naloxone
Pentazocine and Naloxone Hydrochlorides Tablets USP Rx only
Approved
Approval ID
05a17f16-c982-4a54-80cd-079959ab49a7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 20, 2010
Manufacturers
FDA
Keltman Pharmaceuticals Inc.
DUNS: 362861077
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68387-531
Application NumberANDA074736
Product Classification
M
Marketing Category
C73584
G
Generic Name
PENTAZOCINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateJuly 20, 2010
FDA Product Classification
INGREDIENTS (11)
NALOXONE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 1
Code: F850569PQR
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
PENTAZOCINE HYDROCHLORIDEActive
Quantity: 50 mg in 1 1
Code: A36BXO4PPX
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT