cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler bryant ranch prepack
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 63629-1213
Product ID 63629-1213_fc117ad1-470d-c16e-e053-6394a90a0461
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077797
Listing Expiration 2026-12-31
Marketing Start 2017-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 636291213
Hyphenated Format 63629-1213

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 ANDA077797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (63629-1213-1)
source: ndc

Packages (1)

63629-1213-1 100 TABLET, FILM COATED in 1 BOTTLE (63629-1213-1)

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": "fc117ad1-470d-c16e-e053-6394a90a0461", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["0f96512c-8ac8-4643-ac3d-f2a6ce755abe"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (63629-1213-1)", "package_ndc": "63629-1213-1", "marketing_start_date": "20210114"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "63629-1213_fc117ad1-470d-c16e-e053-6394a90a0461", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "63629-1213", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA077797", "marketing_category": "ANDA", "marketing_start_date": "20170330", "listing_expiration_date": "20261231"}