cyclobenzaprine hcl

Generic: cyclobenzaprine hcl

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hcl
Generic Name cyclobenzaprine hcl
Labeler advanced rx of tennessee, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0016
Product ID 80425-0016_2a985779-947a-6d0e-e063-6294a90aa2a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
Marketing Start 2017-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250016
Hyphenated Format 80425-0016

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 hcl (source: ndc)
Generic Name cyclobenzaprine hcl (source: ndc)
Application Number ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0016-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0016-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0016-3)
  • 120 TABLET, FILM COATED in 1 BOTTLE (80425-0016-4)
source: ndc

Packages (4)

80425-0016-1 60 TABLET, FILM COATED in 1 BOTTLE (80425-0016-1) 80425-0016-2 30 TABLET, FILM COATED in 1 BOTTLE (80425-0016-2) 80425-0016-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0016-3) 80425-0016-4 120 TABLET, FILM COATED in 1 BOTTLE (80425-0016-4)

Ingredients (1)

cyclobenzaprine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Cyclobenzaprine HCL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2a985779-947a-6d0e-e063-6294a90aa2a7", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["afca1267-4d8f-7453-e053-2995a90a865c"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0016-1)", "package_ndc": "80425-0016-1", "marketing_start_date": "20170531"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0016-2)", "package_ndc": "80425-0016-2", "marketing_start_date": "20170531"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0016-3)", "package_ndc": "80425-0016-3", "marketing_start_date": "20170531"}, {"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (80425-0016-4)", "package_ndc": "80425-0016-4", "marketing_start_date": "20170531"}], "brand_name": "Cyclobenzaprine HCL", "product_id": "80425-0016_2a985779-947a-6d0e-e063-6294a90aa2a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "80425-0016", "generic_name": "Cyclobenzaprine HCL", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine HCL", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20261231"}