cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8637
Product ID 68788-8637_ddec1539-13ab-4c54-827c-63c12ed70580
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213324
Listing Expiration 2026-12-31
Marketing Start 2024-04-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888637
Hyphenated Format 68788-8637

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
  • 20 TABLET, FILM COATED in 1 BOTTLE (68788-8637-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68788-8637-3)
  • 15 TABLET, FILM COATED in 1 BOTTLE (68788-8637-5)
  • 60 TABLET, FILM COATED in 1 BOTTLE (68788-8637-6)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68788-8637-9)
source: ndc

Packages (5)

68788-8637-2 20 TABLET, FILM COATED in 1 BOTTLE (68788-8637-2) 68788-8637-3 30 TABLET, FILM COATED in 1 BOTTLE (68788-8637-3) 68788-8637-5 15 TABLET, FILM COATED in 1 BOTTLE (68788-8637-5) 68788-8637-6 60 TABLET, FILM COATED in 1 BOTTLE (68788-8637-6) 68788-8637-9 90 TABLET, FILM COATED in 1 BOTTLE (68788-8637-9)

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": "ddec1539-13ab-4c54-827c-63c12ed70580", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["348c7ad4-b380-4b78-88f4-106b94079f52"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68788-8637-2)", "package_ndc": "68788-8637-2", "marketing_start_date": "20240419"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68788-8637-3)", "package_ndc": "68788-8637-3", "marketing_start_date": "20240419"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (68788-8637-5)", "package_ndc": "68788-8637-5", "marketing_start_date": "20240419"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (68788-8637-6)", "package_ndc": "68788-8637-6", "marketing_start_date": "20240419"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68788-8637-9)", "package_ndc": "68788-8637-9", "marketing_start_date": "20240419"}], "brand_name": "Cyclobenzaprine hydrochloride", "product_id": "68788-8637_ddec1539-13ab-4c54-827c-63c12ed70580", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "68788-8637", "generic_name": "Cyclobenzaprine hydrochloride", "labeler_name": "Preferred Pharmaceuticals Inc.", "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": "20240419", "listing_expiration_date": "20261231"}