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FDA Approval

Cyclobenzaprine Hydrochloride

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

FDA Approval Summary

Company

Asclemed USA, Inc.

DUNS: 059888437

Effective Date

September 3, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Cyclobenzaprine(10 mg in 1 1)

Manufacturing Establishments1

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

ASCLEMED USA INC. DBA ENOVACHEM

Labeler

Asclemed USA, Inc.

DUNS Number

059888437

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cyclobenzaprine Hydrochloride

Product Details

NDC Product Code

76420-271

Application Number

ANDA071611

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 3, 2022

Ingredients

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CyclobenzaprineActive

Code: 0VE05JYS2PClass: ACTIBQuantity: 10 mg in 1 1

Cyclobenzaprine Hydrochloride

Product Details

NDC Product Code

76420-269

Application Number

ANDA071611

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 3, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

CyclobenzaprineActive

Code: 0VE05JYS2PClass: ACTIBQuantity: 5 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

Cyclobenzaprine Hydrochloride

Product Details

NDC Product Code

76420-268

Application Number

ANDA071611

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

September 3, 2022

Ingredients

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

CROSCARMELLOSE SODIUMInactive

Code: M28OL1HH48Class: IACT

HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive

Code: RFW2ET671PClass: IACT

CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive

Code: L11K75P92JClass: IACT

HYPROMELLOSESInactive

Code: 3NXW29V3WOClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

CELLULOSE, MICROCRYSTALLINEInactive

Code: OP1R32D61UClass: IACT

POLYETHYLENE GLYCOL, UNSPECIFIEDInactive

Code: 3WJQ0SDW1AClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

CyclobenzaprineActive

Code: 0VE05JYS2PClass: ACTIBQuantity: 7.5 mg in 1 1

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