cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-545
Product ID 72189-545_4c4c0bb8-ab70-3f03-e063-6294a90af0b9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2027-12-31
Marketing Start 2024-04-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189545
Hyphenated Format 72189-545

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 (72189-545-15)
  • 21 TABLET, FILM COATED in 1 BOTTLE (72189-545-21)
  • 30 TABLET, FILM COATED in 1 BOTTLE (72189-545-30)
  • 60 TABLET, FILM COATED in 1 BOTTLE (72189-545-60)
  • 90 TABLET, FILM COATED in 1 BOTTLE (72189-545-90)
source: ndc

Packages (5)

72189-545-15 15 TABLET, FILM COATED in 1 BOTTLE (72189-545-15) 72189-545-21 21 TABLET, FILM COATED in 1 BOTTLE (72189-545-21) 72189-545-30 30 TABLET, FILM COATED in 1 BOTTLE (72189-545-30) 72189-545-60 60 TABLET, FILM COATED in 1 BOTTLE (72189-545-60) 72189-545-90 90 TABLET, FILM COATED in 1 BOTTLE (72189-545-90)

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": "4c4c0bb8-ab70-3f03-e063-6294a90af0b9", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["15aad4af-5c05-be36-e063-6294a90a9bb3"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (72189-545-15)", "package_ndc": "72189-545-15", "marketing_start_date": "20240409"}, {"sample": false, "description": "21 TABLET, FILM COATED in 1 BOTTLE (72189-545-21)", "package_ndc": "72189-545-21", "marketing_start_date": "20240409"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (72189-545-30)", "package_ndc": "72189-545-30", "marketing_start_date": "20240409"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (72189-545-60)", "package_ndc": "72189-545-60", "marketing_start_date": "20240409"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (72189-545-90)", "package_ndc": "72189-545-90", "marketing_start_date": "20240409"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "72189-545_4c4c0bb8-ab70-3f03-e063-6294a90af0b9", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72189-545", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Direct_Rx", "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": "20240409", "listing_expiration_date": "20271231"}