cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler asclemed usa, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 7.5 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-268
Product ID 76420-268_e7bfa09d-7e18-d2bf-e053-2995a90a9145
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA071611
Listing Expiration 2026-12-31
Marketing Start 2021-07-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420268
Hyphenated Format 76420-268

Supplemental Identifiers

RxCUI
828299 828320 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 ANDA071611 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 1 TABLET, FILM COATED in 1 BOTTLE (76420-268-01)
  • 2 TABLET, FILM COATED in 1 BOTTLE (76420-268-02)
  • 7 TABLET, FILM COATED in 1 BOTTLE (76420-268-07)
  • 100 TABLET, FILM COATED in 1 BOTTLE (76420-268-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE (76420-268-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (76420-268-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (76420-268-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (76420-268-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (76420-268-90)
source: ndc

Packages (9)

76420-268-01 1 TABLET, FILM COATED in 1 BOTTLE (76420-268-01) 76420-268-02 2 TABLET, FILM COATED in 1 BOTTLE (76420-268-02) 76420-268-07 7 TABLET, FILM COATED in 1 BOTTLE (76420-268-07) 76420-268-10 100 TABLET, FILM COATED in 1 BOTTLE (76420-268-10) 76420-268-15 15 TABLET, FILM COATED in 1 BOTTLE (76420-268-15) 76420-268-20 20 TABLET, FILM COATED in 1 BOTTLE (76420-268-20) 76420-268-30 30 TABLET, FILM COATED in 1 BOTTLE (76420-268-30) 76420-268-60 60 TABLET, FILM COATED in 1 BOTTLE (76420-268-60) 76420-268-90 90 TABLET, FILM COATED in 1 BOTTLE (76420-268-90)

Ingredients (1)

cyclobenzaprine hydrochloride (7.5 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": "e7bfa09d-7e18-d2bf-e053-2995a90a9145", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["f8dec4e2-3151-4a79-b194-a11a57ada0b6"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET, FILM COATED in 1 BOTTLE (76420-268-01)", "package_ndc": "76420-268-01", "marketing_start_date": "20220903"}, {"sample": false, "description": "2 TABLET, FILM COATED in 1 BOTTLE (76420-268-02)", "package_ndc": "76420-268-02", "marketing_start_date": "20220903"}, {"sample": false, "description": "7 TABLET, FILM COATED in 1 BOTTLE (76420-268-07)", "package_ndc": "76420-268-07", "marketing_start_date": "20220903"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (76420-268-10)", "package_ndc": "76420-268-10", "marketing_start_date": "20220903"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (76420-268-15)", "package_ndc": "76420-268-15", "marketing_start_date": "20220903"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (76420-268-20)", "package_ndc": "76420-268-20", "marketing_start_date": "20220903"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (76420-268-30)", "package_ndc": "76420-268-30", "marketing_start_date": "20220903"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76420-268-60)", "package_ndc": "76420-268-60", "marketing_start_date": "20220903"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (76420-268-90)", "package_ndc": "76420-268-90", "marketing_start_date": "20220903"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "76420-268_e7bfa09d-7e18-d2bf-e053-2995a90a9145", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "76420-268", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA071611", "marketing_category": "ANDA", "marketing_start_date": "20210720", "listing_expiration_date": "20261231"}