cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: ncs healthcare of ky, llc dba vangard labs
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler ncs healthcare of ky, llc dba vangard labs
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs

Identifiers & Regulatory

Product NDC 0615-8508
Product ID 0615-8508_dc545abc-ee5b-4f19-ba1e-d0643186f2f4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213324
Listing Expiration 2026-12-31
Marketing Start 2020-07-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 06158508
Hyphenated Format 0615-8508

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 ANDA213324 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-05)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-39)
source: ndc

Packages (2)

0615-8508-05 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-05) 0615-8508-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-39)

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": "dc545abc-ee5b-4f19-ba1e-d0643186f2f4", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828320"], "spl_set_id": ["e332763b-00c6-41bf-84ae-a07d9ef79697"], "manufacturer_name": ["NCS HealthCare of KY, LLC dba Vangard Labs"]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-05)", "package_ndc": "0615-8508-05", "marketing_start_date": "20240516"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8508-39)", "package_ndc": "0615-8508-39", "marketing_start_date": "20240516"}], "brand_name": "Cyclobenzaprine hydrochloride", "product_id": "0615-8508_dc545abc-ee5b-4f19-ba1e-d0643186f2f4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0615-8508", "generic_name": "Cyclobenzaprine hydrochloride", "labeler_name": "NCS HealthCare of KY, LLC dba Vangard Labs", "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_start_date": "20200706", "listing_expiration_date": "20261231"}