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Cyclobenzaprine Hydrochloride

CYCLOBENZAPRINE HYDROCHLORIDE TABLETS, USP Rx only

Approved
Approval ID

f7821fc7-c11b-465e-9d33-a399e09926ae

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 1, 2017

Manufacturers
FDA

IPG PHARMACEUTICALS, INC.

DUNS: 080441238

Products 1

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

Cyclobenzaprine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code71085-010
Application NumberANDA078722
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateAugust 1, 2017
FDA Product Classification

INGREDIENTS (9)

CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
HYDROXYPROPYL CELLULOSE (TYPE H)Inactive
Code: RFW2ET671P
Classification: IACT

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Cyclobenzaprine Hydrochloride - FDA Drug Approval Details