cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler a-s medication solutions
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-5756
Product ID 50090-5756_26f5cef8-35eb-4cc3-b7b4-7f48b1e3526c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213324
Listing Expiration 2026-12-31
Marketing Start 2020-07-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500905756
Hyphenated Format 50090-5756

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 ANDA213324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0)
  • 20 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1)
  • 90 TABLET, FILM COATED in 1 BOTTLE (50090-5756-2)
  • 24 TABLET, FILM COATED in 1 BOTTLE (50090-5756-3)
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-5756-4)
source: ndc

Packages (5)

50090-5756-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0) 50090-5756-1 20 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1) 50090-5756-2 90 TABLET, FILM COATED in 1 BOTTLE (50090-5756-2) 50090-5756-3 24 TABLET, FILM COATED in 1 BOTTLE (50090-5756-3) 50090-5756-4 10 TABLET, FILM COATED in 1 BOTTLE (50090-5756-4)

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": "26f5cef8-35eb-4cc3-b7b4-7f48b1e3526c", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["f2286776-a7de-42dc-b745-d250e741eeb6"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5756-0)", "package_ndc": "50090-5756-0", "marketing_start_date": "20211001"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (50090-5756-1)", "package_ndc": "50090-5756-1", "marketing_start_date": "20211001"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (50090-5756-2)", "package_ndc": "50090-5756-2", "marketing_start_date": "20211001"}, {"sample": false, "description": "24 TABLET, FILM COATED in 1 BOTTLE (50090-5756-3)", "package_ndc": "50090-5756-3", "marketing_start_date": "20211101"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-5756-4)", "package_ndc": "50090-5756-4", "marketing_start_date": "20240517"}], "brand_name": "Cyclobenzaprine hydrochloride", "product_id": "50090-5756_26f5cef8-35eb-4cc3-b7b4-7f48b1e3526c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50090-5756", "generic_name": "Cyclobenzaprine hydrochloride", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213324", "marketing_category": "ANDA", "marketing_start_date": "20200706", "listing_expiration_date": "20261231"}