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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

DUNS: 173360061

Effective Date

January 12, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Hydrocodone(5 mg in 1 1)

Acetaminophen(300 mg in 1 1)

Registrants1

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

DUNS Number

079385868

Manufacturing Establishments1

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

Labeler

KVK-Tech, Inc.

Registrant

ABHAI LLC

DUNS Number

173360061

Products6

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

10702-192

Application Number

ANDA209036

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

10702-190

Application Number

ANDA209037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1

AcetaminophenActive

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

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

10702-194

Application Number

ANDA209036

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

10702-193

Application Number

ANDA209036

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 7.5 mg in 1 1

AcetaminophenActive

Code: 362O9ITL9DClass: ACTIBQuantity: 300 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

10702-191

Application Number

ANDA209037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 10 mg in 1 1

AcetaminophenActive

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

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

Hydrocodone Bitartrate and Acetaminophen

Product Details

NDC Product Code

10702-189

Application Number

ANDA209037

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

January 12, 2024

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSPOVIDONEInactive

Code: 2S7830E561Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

STARCH, PREGELATINIZED CORNInactive

Code: O8232NY3SJClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

AcetaminophenActive

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

HydrocodoneActive

Code: NO70W886KKClass: ACTIBQuantity: 5 mg in 1 1

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