cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

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

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
NuCare Pharmaceutuicals,Inc.

Identifiers & Regulatory

Product NDC 68071-4655
Product ID 68071-4655_48364978-c5f5-6e2c-e063-6394a90a593a
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 680714655
Hyphenated Format 68071-4655

Supplemental Identifiers

RxCUI
828320
UPC
0368071465532
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
  • 12 TABLET, FILM COATED in 1 BOTTLE (68071-4655-2)
  • 30 TABLET, FILM COATED in 1 BOTTLE (68071-4655-3)
source: ndc

Packages (2)

68071-4655-2 12 TABLET, FILM COATED in 1 BOTTLE (68071-4655-2) 68071-4655-3 30 TABLET, FILM COATED in 1 BOTTLE (68071-4655-3)

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": "48364978-c5f5-6e2c-e063-6394a90a593a", "openfda": {"upc": ["0368071465532"], "unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["7c732db1-8321-82a4-e053-2991aa0aa8a0"], "manufacturer_name": ["NuCare Pharmaceutuicals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "12 TABLET, FILM COATED in 1 BOTTLE (68071-4655-2)", "package_ndc": "68071-4655-2", "marketing_start_date": "20181207"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (68071-4655-3)", "package_ndc": "68071-4655-3", "marketing_start_date": "20181207"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "68071-4655_48364978-c5f5-6e2c-e063-6394a90a593a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "68071-4655", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "NuCare Pharmaceutuicals,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": "20271231"}