cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-094
Product ID 63187-094_6d258146-9e61-40a6-b433-d5fb21aecc5e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078048
Listing Expiration 2026-12-31
Marketing Start 2014-07-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187094
Hyphenated Format 63187-094

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 ANDA078048 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE (63187-094-10)
  • 15 TABLET, FILM COATED in 1 BOTTLE (63187-094-15)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63187-094-30)
  • 40 TABLET, FILM COATED in 1 BOTTLE (63187-094-40)
  • 60 TABLET, FILM COATED in 1 BOTTLE (63187-094-60)
  • 120 TABLET, FILM COATED in 1 BOTTLE (63187-094-72)
  • 180 TABLET, FILM COATED in 1 BOTTLE (63187-094-78)
  • 90 TABLET, FILM COATED in 1 BOTTLE (63187-094-90)
source: ndc

Packages (8)

63187-094-10 10 TABLET, FILM COATED in 1 BOTTLE (63187-094-10) 63187-094-15 15 TABLET, FILM COATED in 1 BOTTLE (63187-094-15) 63187-094-30 30 TABLET, FILM COATED in 1 BOTTLE (63187-094-30) 63187-094-40 40 TABLET, FILM COATED in 1 BOTTLE (63187-094-40) 63187-094-60 60 TABLET, FILM COATED in 1 BOTTLE (63187-094-60) 63187-094-72 120 TABLET, FILM COATED in 1 BOTTLE (63187-094-72) 63187-094-78 180 TABLET, FILM COATED in 1 BOTTLE (63187-094-78) 63187-094-90 90 TABLET, FILM COATED in 1 BOTTLE (63187-094-90)

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": "6d258146-9e61-40a6-b433-d5fb21aecc5e", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["f14bc532-e30f-490f-b97b-d0dab9a2ba0c"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE (63187-094-10)", "package_ndc": "63187-094-10", "marketing_start_date": "20180601"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE (63187-094-15)", "package_ndc": "63187-094-15", "marketing_start_date": "20200113"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63187-094-30)", "package_ndc": "63187-094-30", "marketing_start_date": "20150701"}, {"sample": false, "description": "40 TABLET, FILM COATED in 1 BOTTLE (63187-094-40)", "package_ndc": "63187-094-40", "marketing_start_date": "20200324"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (63187-094-60)", "package_ndc": "63187-094-60", "marketing_start_date": "20150701"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (63187-094-72)", "package_ndc": "63187-094-72", "marketing_start_date": "20150701"}, {"sample": false, "description": "180 TABLET, FILM COATED in 1 BOTTLE (63187-094-78)", "package_ndc": "63187-094-78", "marketing_start_date": "20150701"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (63187-094-90)", "package_ndc": "63187-094-90", "marketing_start_date": "20150701"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "63187-094_6d258146-9e61-40a6-b433-d5fb21aecc5e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "63187-094", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078048", "marketing_category": "ANDA", "marketing_start_date": "20140731", "listing_expiration_date": "20261231"}