cyclobenzaprine hydrochloride

Generic: cyclobenzaprine

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

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer
Northwind Health Company, LLC

Identifiers & Regulatory

Product NDC 51655-973
Product ID 51655-973_4960a71d-10d7-6f03-e063-6394a90a710f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090478
Listing Expiration 2027-12-31
Marketing Start 2022-05-04

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 51655973
Hyphenated Format 51655-973

Supplemental Identifiers

RxCUI
828348
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 (source: ndc)
Application Number ANDA090478 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-20)
  • 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-25)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-52)
  • 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-53)
  • 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-54)
  • 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-87)
source: ndc

Packages (6)

51655-973-20 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-20) 51655-973-25 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-25) 51655-973-52 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-52) 51655-973-53 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-53) 51655-973-54 15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-54) 51655-973-87 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-87)

Ingredients (1)

cyclobenzaprine hydrochloride (10 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": "4960a71d-10d7-6f03-e063-6394a90a710f", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["e04eea45-12ec-4d2b-e053-2a95a90a6b76"], "manufacturer_name": ["Northwind Health Company, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-20)", "package_ndc": "51655-973-20", "marketing_start_date": "20221017"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-25)", "package_ndc": "51655-973-25", "marketing_start_date": "20220906"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-52)", "package_ndc": "51655-973-52", "marketing_start_date": "20221007"}, {"sample": false, "description": "10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-53)", "package_ndc": "51655-973-53", "marketing_start_date": "20220727"}, {"sample": false, "description": "15 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-54)", "package_ndc": "51655-973-54", "marketing_start_date": "20220824"}, {"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-973-87)", "package_ndc": "51655-973-87", "marketing_start_date": "20220504"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "51655-973_4960a71d-10d7-6f03-e063-6394a90a710f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "51655-973", "generic_name": "Cyclobenzaprine", "labeler_name": "Northwind Health Company, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "10 mg/1"}], "application_number": "ANDA090478", "marketing_category": "ANDA", "marketing_start_date": "20220504", "listing_expiration_date": "20271231"}