cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: unichem pharmaceuticals (usa), inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler unichem pharmaceuticals (usa), inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Unichem Pharmaceuticals (USA), Inc.

Identifiers & Regulatory

Product NDC 29300-413
Product ID 29300-413_cc113cd6-8904-4485-b1b2-15dd5ff7468b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213324
Listing Expiration 2026-12-31
Marketing Start 2020-07-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 29300413
Hyphenated Format 29300-413

Supplemental Identifiers

RxCUI
828299 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 ANDA213324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (29300-413-01)
  • 500 TABLET, FILM COATED in 1 BOTTLE (29300-413-05)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (29300-413-10)
  • 90 TABLET, FILM COATED in 1 BOTTLE (29300-413-19)
source: ndc

Packages (4)

29300-413-01 100 TABLET, FILM COATED in 1 BOTTLE (29300-413-01) 29300-413-05 500 TABLET, FILM COATED in 1 BOTTLE (29300-413-05) 29300-413-10 1000 TABLET, FILM COATED in 1 BOTTLE (29300-413-10) 29300-413-19 90 TABLET, FILM COATED in 1 BOTTLE (29300-413-19)

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": "cc113cd6-8904-4485-b1b2-15dd5ff7468b", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828299", "828320", "828348"], "spl_set_id": ["1adcdd8a-30f9-4a7b-853c-948a5589acab"], "manufacturer_name": ["Unichem Pharmaceuticals (USA), Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (29300-413-01)", "package_ndc": "29300-413-01", "marketing_start_date": "20200930"}, {"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (29300-413-05)", "package_ndc": "29300-413-05", "marketing_start_date": "20200930"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (29300-413-10)", "package_ndc": "29300-413-10", "marketing_start_date": "20200930"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (29300-413-19)", "package_ndc": "29300-413-19", "marketing_start_date": "20211118"}], "brand_name": "Cyclobenzaprine hydrochloride", "product_id": "29300-413_cc113cd6-8904-4485-b1b2-15dd5ff7468b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "29300-413", "generic_name": "Cyclobenzaprine hydrochloride", "labeler_name": "Unichem Pharmaceuticals (USA), Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA213324", "marketing_category": "ANDA", "marketing_start_date": "20200706", "listing_expiration_date": "20261231"}