cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-3475
Product ID 68071-3475_2bae3004-5267-7ddf-e063-6394a90aa567
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2026-12-31
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 680713475
Hyphenated Format 68071-3475

Supplemental Identifiers

RxCUI
828320
UPC
0368071347524
UNII
0VE05JYS2P

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
  • 20 TABLET, FILM COATED in 1 BOTTLE (68071-3475-1)
  • 12 TABLET, FILM COATED in 1 BOTTLE (68071-3475-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-3475-3)
  • 14 TABLET, FILM COATED in 1 BOTTLE (68071-3475-4)
  • 90 TABLET, FILM COATED in 1 BOTTLE (68071-3475-9)
source: ndc

Packages (5)

68071-3475-1 20 TABLET, FILM COATED in 1 BOTTLE (68071-3475-1) 68071-3475-2 12 TABLET, FILM COATED in 1 BOTTLE (68071-3475-2) 68071-3475-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-3475-3) 68071-3475-4 14 TABLET, FILM COATED in 1 BOTTLE (68071-3475-4) 68071-3475-9 90 TABLET, FILM COATED in 1 BOTTLE (68071-3475-9)

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": "2bae3004-5267-7ddf-e063-6394a90aa567", "openfda": {"upc": ["0368071347524"], "unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["01e18825-1cf9-a98c-e063-6294a90ae0a4"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (68071-3475-1)", "package_ndc": "68071-3475-1", "marketing_start_date": "20230801"}, {"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (68071-3475-2)", "package_ndc": "68071-3475-2", "marketing_start_date": "20230801"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-3475-3)", "package_ndc": "68071-3475-3", "marketing_start_date": "20230801"}, {"sample": false, "description": "14 TABLET, FILM COATED in 1 BOTTLE (68071-3475-4)", "package_ndc": "68071-3475-4", "marketing_start_date": "20240923"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (68071-3475-9)", "package_ndc": "68071-3475-9", "marketing_start_date": "20250114"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "68071-3475_2bae3004-5267-7ddf-e063-6394a90aa567", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "68071-3475", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "20261231"}