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 5 mg/1

Manufacturer
Quality Care Products, LLC

Identifiers & Regulatory

Product NDC 55700-926
Product ID 55700-926_bcc88669-9da7-4a66-8add-b6f439c0b52e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213324
Marketing Start 2021-10-05
Marketing End 2026-03-31

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55700926
Hyphenated Format 55700-926

Supplemental Identifiers

RxCUI
828320 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 hydrochloride (source: ndc)
Application Number ANDA213324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 120 TABLET, FILM COATED in 1 BOTTLE (55700-926-01)
  • 30 TABLET, FILM COATED in 1 BOTTLE (55700-926-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (55700-926-90)
source: ndc

Packages (3)

55700-926-01 120 TABLET, FILM COATED in 1 BOTTLE (55700-926-01) 55700-926-30 30 TABLET, FILM COATED in 1 BOTTLE (55700-926-30) 55700-926-90 90 TABLET, FILM COATED in 1 BOTTLE (55700-926-90)

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": "bcc88669-9da7-4a66-8add-b6f439c0b52e", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["19a54d55-a79a-48c0-89d0-dedd0dcf9f45"], "manufacturer_name": ["Quality Care Products, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "120 TABLET, FILM COATED in 1 BOTTLE (55700-926-01)", "package_ndc": "55700-926-01", "marketing_end_date": "20260331", "marketing_start_date": "20211005"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (55700-926-30)", "package_ndc": "55700-926-30", "marketing_end_date": "20260331", "marketing_start_date": "20211005"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (55700-926-90)", "package_ndc": "55700-926-90", "marketing_end_date": "20260331", "marketing_start_date": "20211005"}], "brand_name": "Cyclobenzaprine hydrochloride", "product_id": "55700-926_bcc88669-9da7-4a66-8add-b6f439c0b52e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "55700-926", "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": "5 mg/1"}], "application_number": "ANDA213324", "marketing_category": "ANDA", "marketing_end_date": "20260331", "marketing_start_date": "20211005"}