cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-540
Product ID 53746-540_b0e32570-da9f-4fa8-a0a2-0334fce7ff7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078218
Listing Expiration 2026-12-31
Marketing Start 2010-02-18

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746540
Hyphenated Format 53746-540

Supplemental Identifiers

RxCUI
828320 828348
UPC
0353746540010 0353746541017
UNII
0VE05JYS2P

Packaging Origin

Original Packager
true

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 ANDA078218 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10)
source: ndc

Packages (3)

53746-540-01 100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01) 53746-540-05 500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05) 53746-540-10 1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10)

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": "b0e32570-da9f-4fa8-a0a2-0334fce7ff7a", "openfda": {"upc": ["0353746540010", "0353746541017"], "unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["31bb92f6-ec8c-4636-8b07-8814417fe78e"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (53746-540-01)", "package_ndc": "53746-540-01", "marketing_start_date": "20100218"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (53746-540-05)", "package_ndc": "53746-540-05", "marketing_start_date": "20100218"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (53746-540-10)", "package_ndc": "53746-540-10", "marketing_start_date": "20100218"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "53746-540_b0e32570-da9f-4fa8-a0a2-0334fce7ff7a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "53746-540", "generic_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOBENZAPRINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078218", "marketing_category": "ANDA", "marketing_start_date": "20100218", "listing_expiration_date": "20261231"}