cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7401
Product ID 0904-7401_01d0daef-106b-4557-95d2-380a993ba9f1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078643
Listing Expiration 2027-12-31
Marketing Start 2008-09-26

Pharmacologic Class

Classes
centrally-mediated muscle relaxation [pe] muscle relaxant [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047401
Hyphenated Format 0904-7401

Supplemental Identifiers

RxCUI
828320 828348
UNII
0VE05JYS2P

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cyclobenzaprine hydrochloride (source: ndc)
Generic Name cyclobenzaprine hydrochloride (source: ndc)
Application Number ANDA078643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 CARTON (0904-7401-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

0904-7401-61 100 BLISTER PACK in 1 CARTON (0904-7401-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

cyclobenzaprine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "01d0daef-106b-4557-95d2-380a993ba9f1", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["508e310e-067a-4f95-869a-e1da49aabe94"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-7401-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-7401-61", "marketing_start_date": "20240221"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "0904-7401_01d0daef-106b-4557-95d2-380a993ba9f1", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0904-7401", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078643", "marketing_category": "ANDA", "marketing_start_date": "20080926", "listing_expiration_date": "20271231"}