cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: northwind health company, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler northwind health company, llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 82868-008
Product ID 82868-008_46dc8f32-6929-a243-e063-6394a90a19f8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078643
Listing Expiration 2026-12-31
Marketing Start 2024-04-29

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82868008
Hyphenated Format 82868-008

Supplemental Identifiers

RxCUI
828320
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 ANDA078643 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-008-30)
source: ndc

Packages (1)

82868-008-30 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-008-30)

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": "46dc8f32-6929-a243-e063-6394a90a19f8", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["1912d134-a909-5511-e063-6294a90aea29"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82868-008-30)", "package_ndc": "82868-008-30", "marketing_start_date": "20240429"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "82868-008_46dc8f32-6929-a243-e063-6394a90a19f8", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "82868-008", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA078643", "marketing_category": "ANDA", "marketing_start_date": "20240429", "listing_expiration_date": "20261231"}