Pentazocine HCl and Acetaminophen
Pentazocine HCl and Acetaminophen Tablets C-IV Rx only 30276-4
Approved
Approval ID
fbb6a064-59a6-4e1c-bbb6-5934c1505c4f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2010
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code21695-634
Application NumberANDA074699
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pentazocine Hydrochloride and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateMay 30, 2006
FDA Product Classification
INGREDIENTS (11)
AcetaminophenActive
Quantity: 650 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
Pentazocine hydrochlorideActive
Quantity: 25 mg in 1 1
Code: A36BXO4PPX
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
stearic acidInactive
Code: 4ELV7Z65AP
Classification: IACT