cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: cardinal health 107, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler cardinal health 107, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Cardinal Health 107, LLC

Identifiers & Regulatory

Product NDC 55154-0190
Product ID 55154-0190_df902d94-9d2b-4139-aebb-3eb6b8b8cd54
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078643
Listing Expiration 2026-12-31
Marketing Start 2025-10-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 551540190
Hyphenated Format 55154-0190

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 ANDA078643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 10 BLISTER PACK in 1 BAG (55154-0190-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

55154-0190-0 10 BLISTER PACK in 1 BAG (55154-0190-0) / 1 TABLET, FILM COATED in 1 BLISTER PACK

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": "df902d94-9d2b-4139-aebb-3eb6b8b8cd54", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["df902d94-9d2b-4139-aebb-3eb6b8b8cd54"], "manufacturer_name": ["Cardinal Health 107, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 BAG (55154-0190-0)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "55154-0190-0", "marketing_start_date": "20251010"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "55154-0190_df902d94-9d2b-4139-aebb-3eb6b8b8cd54", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "55154-0190", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Cardinal Health 107, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA078643", "marketing_category": "ANDA", "marketing_start_date": "20251010", "listing_expiration_date": "20261231"}