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 50090-5712
Product ID 50090-5712_39b5ac79-ad9a-4b68-ac00-f28408f7d31d
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 500905712
Hyphenated Format 50090-5712

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 ANDA213324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 TABLET, FILM COATED in 1 BOTTLE (50090-5712-0)
  • 12 TABLET, FILM COATED in 1 BOTTLE (50090-5712-1)
  • 42 TABLET, FILM COATED in 1 BOTTLE (50090-5712-4)
  • 6 TABLET, FILM COATED in 1 BOTTLE (50090-5712-8)
source: ndc

Packages (4)

50090-5712-0 3 TABLET, FILM COATED in 1 BOTTLE (50090-5712-0) 50090-5712-1 12 TABLET, FILM COATED in 1 BOTTLE (50090-5712-1) 50090-5712-4 42 TABLET, FILM COATED in 1 BOTTLE (50090-5712-4) 50090-5712-8 6 TABLET, FILM COATED in 1 BOTTLE (50090-5712-8)

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": "39b5ac79-ad9a-4b68-ac00-f28408f7d31d", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["bf3c4c2e-b089-4f83-9c6a-7ca9d9abd3ba"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "3 TABLET, FILM COATED in 1 BOTTLE (50090-5712-0)", "package_ndc": "50090-5712-0", "marketing_start_date": "20210924"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (50090-5712-1)", "package_ndc": "50090-5712-1", "marketing_start_date": "20210924"}, {"sample": false, "description": "42 TABLET, FILM COATED in 1 BOTTLE (50090-5712-4)", "package_ndc": "50090-5712-4", "marketing_start_date": "20210924"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE (50090-5712-8)", "package_ndc": "50090-5712-8", "marketing_start_date": "20210924"}], "brand_name": "Cyclobenzaprine hydrochloride", "product_id": "50090-5712_39b5ac79-ad9a-4b68-ac00-f28408f7d31d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50090-5712", "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": "ANDA213324", "marketing_category": "ANDA", "marketing_start_date": "20200706", "listing_expiration_date": "20261231"}