Hydrocodone Bitartrate and Acetaminophen
Hydrocodone/Apap 10/325mg tab
Approved
Approval ID
bc2f912c-4a25-4b75-e053-2995a90a932b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2021
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 Code67296-1425
Application NumberANDA211487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 25, 2021
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT