cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: advagen pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler advagen pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Advagen Pharma Limited

Identifiers & Regulatory

Product NDC 72888-012
Product ID 72888-012_484568be-57f8-943e-e063-6394a90a589b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2027-12-31
Marketing Start 2017-05-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72888012
Hyphenated Format 72888-012

Supplemental Identifiers

RxCUI
828299 828320 828348
UPC
0372888012001 0372888012018 0372888012056 0372888014005 0372888014050 0372888013015 0372888014012
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 ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 1000 TABLET, FILM COATED in 1 BOTTLE (72888-012-00)
  • 100 TABLET, FILM COATED in 1 BOTTLE (72888-012-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (72888-012-05)
source: ndc

Packages (3)

72888-012-00 1000 TABLET, FILM COATED in 1 BOTTLE (72888-012-00) 72888-012-01 100 TABLET, FILM COATED in 1 BOTTLE (72888-012-01) 72888-012-05 500 TABLET, FILM COATED in 1 BOTTLE (72888-012-05)

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": "484568be-57f8-943e-e063-6394a90a589b", "openfda": {"upc": ["0372888012001", "0372888012018", "0372888012056", "0372888014005", "0372888014050", "0372888013015", "0372888014012"], "unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["b2169957-9083-412c-a175-3071860c2b43"], "manufacturer_name": ["Advagen Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (72888-012-00)", "package_ndc": "72888-012-00", "marketing_start_date": "20211101"}, {"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (72888-012-01)", "package_ndc": "72888-012-01", "marketing_start_date": "20170531"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (72888-012-05)", "package_ndc": "72888-012-05", "marketing_start_date": "20170531"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "72888-012_484568be-57f8-943e-e063-6394a90a589b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72888-012", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Advagen Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOBENZAPRINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20170531", "listing_expiration_date": "20271231"}