cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: jubilant cadista pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler jubilant cadista pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 7.5 mg/1

Manufacturer
Jubilant Cadista Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 59746-735
Product ID 59746-735_a18ba005-b6de-4c5b-a837-489d74022084
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077563
Listing Expiration 2026-12-31
Marketing Start 2017-10-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59746735
Hyphenated Format 59746-735

Supplemental Identifiers

RxCUI
828299 828320 828348
UPC
0359746735012 0359746177065 0359746177102
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 ANDA077563 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (59746-735-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (59746-735-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (59746-735-30)
source: ndc

Packages (3)

59746-735-01 100 TABLET, FILM COATED in 1 BOTTLE (59746-735-01) 59746-735-10 1000 TABLET, FILM COATED in 1 BOTTLE (59746-735-10) 59746-735-30 30 TABLET, FILM COATED in 1 BOTTLE (59746-735-30)

Ingredients (1)

cyclobenzaprine hydrochloride (7.5 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": "a18ba005-b6de-4c5b-a837-489d74022084", "openfda": {"upc": ["0359746735012", "0359746177065", "0359746177102"], "unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["592871f6-0eb2-4624-9e10-bd8bf767c002"], "manufacturer_name": ["Jubilant Cadista Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (59746-735-01)", "package_ndc": "59746-735-01", "marketing_start_date": "20171009"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (59746-735-10)", "package_ndc": "59746-735-10", "marketing_start_date": "20171009"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59746-735-30)", "package_ndc": "59746-735-30", "marketing_start_date": "20171009"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "59746-735_a18ba005-b6de-4c5b-a837-489d74022084", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "59746-735", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Jubilant Cadista Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA077563", "marketing_category": "ANDA", "marketing_start_date": "20171009", "listing_expiration_date": "20261231"}