cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: quality care products llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler quality care products llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 7.5 mg/1

Manufacturer
Quality Care Products LLC

Identifiers & Regulatory

Product NDC 55700-239
Product ID 55700-239_0498b9cc-1111-40b9-9605-08c32d167c7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078722
Marketing Start 2015-03-25
Marketing End 2027-12-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55700239
Hyphenated Format 55700-239

Supplemental Identifiers

RxCUI
828299
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 ANDA078722 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 7.5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (55700-239-90)
source: ndc

Packages (1)

55700-239-90 90 TABLET, FILM COATED in 1 BOTTLE (55700-239-90)

Ingredients (1)

cyclobenzaprine hydrochloride (7.5 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": "0498b9cc-1111-40b9-9605-08c32d167c7f", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828299"], "spl_set_id": ["794d350b-6c88-41d5-b68b-3e2c57ee2a4f"], "manufacturer_name": ["Quality Care Products LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (55700-239-90)", "package_ndc": "55700-239-90", "marketing_end_date": "20271231", "marketing_start_date": "20220408"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "55700-239_0498b9cc-1111-40b9-9605-08c32d167c7f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "55700-239", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Quality Care Products LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "7.5 mg/1"}], "application_number": "ANDA078722", "marketing_category": "ANDA", "marketing_end_date": "20271231", "marketing_start_date": "20150325"}