cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: solco healthcare u.s., llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler solco healthcare u.s., llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Solco Healthcare U.S., LLC

Identifiers & Regulatory

Product NDC 43547-399
Product ID 43547-399_0318717e-68e2-48bc-aa86-d34101d2bd25
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077797
Listing Expiration 2026-12-31
Marketing Start 2017-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43547399
Hyphenated Format 43547-399

Supplemental Identifiers

RxCUI
828320 828348
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 ANDA077797 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-01)
  • 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-10)
  • 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-11)
  • 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-50)
source: ndc

Packages (4)

43547-399-01 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-01) 43547-399-10 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-10) 43547-399-11 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-11) 43547-399-50 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-50)

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": "0318717e-68e2-48bc-aa86-d34101d2bd25", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["f558863b-ea3f-4e4b-85e9-edb2573e7151"], "manufacturer_name": ["Solco Healthcare U.S., LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-01)", "package_ndc": "43547-399-01", "marketing_start_date": "20170330"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-10)", "package_ndc": "43547-399-10", "marketing_start_date": "20170330"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-11)", "package_ndc": "43547-399-11", "marketing_start_date": "20170330"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43547-399-50)", "package_ndc": "43547-399-50", "marketing_start_date": "20170330"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "43547-399_0318717e-68e2-48bc-aa86-d34101d2bd25", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "43547-399", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Solco Healthcare U.S., LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA077797", "marketing_category": "ANDA", "marketing_start_date": "20170330", "listing_expiration_date": "20261231"}