Hydrocodone Bitartrate and Acetaminophen
Approved
Approval ID
b9f61b9c-d3f9-47e3-94a3-b5228f96f927
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2023
Manufacturers
FDA
XLCare Pharmaceuticals, Inc.
DUNS: 080991142
Products 4
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 Code72865-201
Application NumberANDA211487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (8)
HYDROCODONE BITARTRATEActive
Quantity: 2.5 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
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-202
Application NumberANDA211487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (8)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
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
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-203
Application NumberANDA211487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (8)
HYDROCODONE BITARTRATEActive
Quantity: 7.5 mg in 1 1
Code: NO70W886KK
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
ACETAMINOPHENActive
Quantity: 325 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
Hydrocodone Bitartrate and Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72865-204
Application NumberANDA211487
Product Classification
M
Marketing Category
C73584
G
Generic Name
Hydrocodone Bitartrate and Acetaminophen
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2023
FDA Product Classification
INGREDIENTS (8)
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
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT