cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: qpharma inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
QPharma Inc

Identifiers & Regulatory

Product NDC 42708-172
Product ID 42708-172_459bb393-8b6b-f9b9-e063-6294a90ad73c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078643
Listing Expiration 2026-12-31
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 42708172
Hyphenated Format 42708-172

Supplemental Identifiers

RxCUI
828320
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
  • 5 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-172-20)
source: ndc

Packages (1)

42708-172-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-172-20)

Ingredients (1)

cyclobenzaprine hydrochloride (5 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": "459bb393-8b6b-f9b9-e063-6294a90ad73c", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["fbe6ba88-0581-50ef-e053-6394a90ab086"], "manufacturer_name": ["QPharma Inc"]}, "finished": true, "packaging": [{"sample": true, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-172-20)", "package_ndc": "42708-172-20", "marketing_start_date": "20230519"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "42708-172_459bb393-8b6b-f9b9-e063-6294a90ad73c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "42708-172", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "QPharma Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078643", "marketing_category": "ANDA", "marketing_start_date": "20080926", "listing_expiration_date": "20261231"}