cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

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

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0498
Product ID 80425-0498_30ca0349-f7a5-388a-e063-6294a90ad02c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
Marketing Start 2025-03-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250498
Hyphenated Format 80425-0498

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
  • 30 TABLET, FILM COATED in 1 BOTTLE (80425-0498-1)
  • 60 TABLET, FILM COATED in 1 BOTTLE (80425-0498-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (80425-0498-3)
source: ndc

Packages (3)

80425-0498-1 30 TABLET, FILM COATED in 1 BOTTLE (80425-0498-1) 80425-0498-2 60 TABLET, FILM COATED in 1 BOTTLE (80425-0498-2) 80425-0498-3 90 TABLET, FILM COATED in 1 BOTTLE (80425-0498-3)

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": "30ca0349-f7a5-388a-e063-6294a90ad02c", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["30ca08c7-4ee3-2f37-e063-6294a90ae31a"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (80425-0498-1)", "package_ndc": "80425-0498-1", "marketing_start_date": "20250320"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (80425-0498-2)", "package_ndc": "80425-0498-2", "marketing_start_date": "20250320"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (80425-0498-3)", "package_ndc": "80425-0498-3", "marketing_start_date": "20250320"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "80425-0498_30ca0349-f7a5-388a-e063-6294a90ad02c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "80425-0498", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Advanced Rx of Tennessee, LLC", "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": "20250320", "listing_expiration_date": "20261231"}