cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler advanced rx of tennessee, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0451
Product ID 80425-0451_259f8ad9-cf83-d416-e063-6294a90a80ca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2024-10-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 804250451
Hyphenated Format 80425-0451

Supplemental Identifiers

RxCUI
828358
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 NDA021777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-1)
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-2)
  • 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-3)
source: ndc

Packages (3)

80425-0451-1 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-1) 80425-0451-2 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-2) 80425-0451-3 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-3)

Ingredients (1)

cyclobenzaprine hydrochloride (15 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": "259f8ad9-cf83-d416-e063-6294a90a80ca", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828358"], "spl_set_id": ["259fb05a-4f45-9c8e-e063-6294a90a4484"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-1)", "package_ndc": "80425-0451-1", "marketing_start_date": "20241029"}, {"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-2)", "package_ndc": "80425-0451-2", "marketing_start_date": "20241029"}, {"sample": false, "description": "90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0451-3)", "package_ndc": "80425-0451-3", "marketing_start_date": "20241029"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "80425-0451_259f8ad9-cf83-d416-e063-6294a90a80ca", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "80425-0451", "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": "15 mg/1"}], "application_number": "NDA021777", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20241029", "listing_expiration_date": "20261231"}