cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: directrx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler directrx
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
DirectRx

Identifiers & Regulatory

Product NDC 72189-283
Product ID 72189-283_2c292ad7-a15f-7642-e063-6394a90a18b8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
Marketing Start 2021-10-19

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189283
Hyphenated Format 72189-283

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 ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BOTTLE (72189-283-15)
  • 20 TABLET, FILM COATED in 1 BOTTLE (72189-283-20)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-283-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72189-283-60)
  • 180 TABLET, FILM COATED in 1 BOTTLE (72189-283-82)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-283-90)
source: ndc

Packages (6)

72189-283-15 15 TABLET, FILM COATED in 1 BOTTLE (72189-283-15) 72189-283-20 20 TABLET, FILM COATED in 1 BOTTLE (72189-283-20) 72189-283-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-283-30) 72189-283-60 60 TABLET, FILM COATED in 1 BOTTLE (72189-283-60) 72189-283-82 180 TABLET, FILM COATED in 1 BOTTLE (72189-283-82) 72189-283-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-283-90)

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": "2c292ad7-a15f-7642-e063-6394a90a18b8", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["ceb56ab8-4a76-6dee-e053-2995a90aab30"], "manufacturer_name": ["DirectRx"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (72189-283-15)", "package_ndc": "72189-283-15", "marketing_start_date": "20211019"}, {"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (72189-283-20)", "package_ndc": "72189-283-20", "marketing_start_date": "20211019"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-283-30)", "package_ndc": "72189-283-30", "marketing_start_date": "20211019"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72189-283-60)", "package_ndc": "72189-283-60", "marketing_start_date": "20211019"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (72189-283-82)", "package_ndc": "72189-283-82", "marketing_start_date": "20211019"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-283-90)", "package_ndc": "72189-283-90", "marketing_start_date": "20211019"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "72189-283_2c292ad7-a15f-7642-e063-6394a90a18b8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72189-283", "generic_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "labeler_name": "DirectRx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOBENZAPRINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20211019", "listing_expiration_date": "20261231"}