cyclobenzaprine hydrochloride

Generic: cyclobenzaprine

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-191
Product ID 50268-191_423db048-ad6b-f3a9-e063-6394a90a192c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090478
Listing Expiration 2026-12-31
Marketing Start 2022-08-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268191
Hyphenated Format 50268-191

Supplemental Identifiers

RxCUI
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 (source: ndc)
Application Number ANDA090478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 BOX (50268-191-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-191-11)
source: ndc

Packages (1)

50268-191-15 50 BLISTER PACK in 1 BOX (50268-191-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-191-11)

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": "423db048-ad6b-f3a9-e063-6394a90a192c", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["e530fd1e-06fd-0432-e053-2995a90adf5f"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-191-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-191-11)", "package_ndc": "50268-191-15", "marketing_start_date": "20220801"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "50268-191_423db048-ad6b-f3a9-e063-6394a90a192c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50268-191", "generic_name": "Cyclobenzaprine", "labeler_name": "AvPAK", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090478", "marketing_category": "ANDA", "marketing_start_date": "20220801", "listing_expiration_date": "20261231"}