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 10 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-4727
Product ID 50090-4727_0d2d2af6-37df-43fe-8222-c1374734d48a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
Marketing Start 2017-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500904727
Hyphenated Format 50090-4727

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 hydrochloride (source: ndc)
Application Number ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (50090-4727-0)
  • 20 TABLET, FILM COATED in 1 BOTTLE (50090-4727-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (50090-4727-2)
  • 60 TABLET, FILM COATED in 1 BOTTLE (50090-4727-3)
  • 100 TABLET, FILM COATED in 1 BOTTLE (50090-4727-4)
  • 7 TABLET, FILM COATED in 1 BOTTLE (50090-4727-6)
  • 14 TABLET, FILM COATED in 1 BOTTLE (50090-4727-7)
  • 21 TABLET, FILM COATED in 1 BOTTLE (50090-4727-8)
  • 10 TABLET, FILM COATED in 1 BOTTLE (50090-4727-9)
source: ndc

Packages (9)

Ingredients (1)

cyclobenzaprine hydrochloride (10 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0d2d2af6-37df-43fe-8222-c1374734d48a", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["eb908b77-741c-473a-b2e9-4f82167c3088"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (50090-4727-0)", "package_ndc": "50090-4727-0", "marketing_start_date": "20191118"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (50090-4727-1)", "package_ndc": "50090-4727-1", "marketing_start_date": "20191118"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (50090-4727-2)", "package_ndc": "50090-4727-2", "marketing_start_date": "20191118"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (50090-4727-3)", "package_ndc": "50090-4727-3", "marketing_start_date": "20191118"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (50090-4727-4)", "package_ndc": "50090-4727-4", "marketing_start_date": "20191118"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (50090-4727-6)", "package_ndc": "50090-4727-6", "marketing_start_date": "20191118"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (50090-4727-7)", "package_ndc": "50090-4727-7", "marketing_start_date": "20191118"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (50090-4727-8)", "package_ndc": "50090-4727-8", "marketing_start_date": "20191118"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (50090-4727-9)", "package_ndc": "50090-4727-9", "marketing_start_date": "20191118"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "50090-4727_0d2d2af6-37df-43fe-8222-c1374734d48a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50090-4727", "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": "10 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20261231"}