Hydrocodone Bitartrate and Acetaminophen
Hydrocodone Bitartrate and Acetaminophen Tablets, USP CII Rx Only
Approved
Approval ID
465d909e-9d32-482d-8a9d-3e49d7be68d0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 31, 2022
Manufacturers
FDA
Major Pharmaceuticals
DUNS: 191427277
Products 3
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 Code0904-6826
Application NumberANDA206245
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-6825
Application NumberANDA206245
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 10 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0904-6824
Application NumberANDA206245
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2022
FDA Product Classification
INGREDIENTS (9)
HYDROCODONE BITARTRATEActive
Quantity: 5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
CrospovidoneInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT