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FDA Approval

Hydrocodone Bitartrate and Acetaminophen

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

Epic Pharma, LLC

DUNS: 827915443

Effective Date

December 27, 2023

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Acetaminophen(325 mg in 1 1)

Hydrocodone(10 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Epic Pharma, LLC

DUNS Number

827915443

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Epic Pharma, LLC

Labeler

Epic Pharma, LLC

Registrant

Epic Pharma, LLC

DUNS Number

827915443

Products3

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

NDC Product Code

42806-113

Application Number

ANDA203863

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 22, 2023

Ingredients

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

D&C YELLOW NO. 10Inactive

Code: 35SW5USQ3GClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

42806-111

Application Number

ANDA203863

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 22, 2023

Ingredients

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

42806-112

Application Number

ANDA203863

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 22, 2023

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 325 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

CROSPOVIDONE, UNSPECIFIEDInactive

Code: 2S7830E561Class: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

STARCH, CORNInactive

Code: O8232NY3SJClass: IACT

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