HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Hydrocodone Bitartrate and Acetaminophen Tablets USP CII 5 mg/325 mg, 7.5 mg/325 mg and 10 mg/325 mg Revised: AUGUST 2020
Approved
Approval ID
0ab05226-0f18-c929-e063-6294a90ad95a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
RedPharm Drug, Inc
DUNS: 828374897
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67296-1890
Application NumberANDA040409
Product Classification
M
Marketing Category
C73584
G
Generic Name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Product Specifications
Route of AdministrationORAL
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (9)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT