cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: medcore llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

cyclobenzaprine hydrochloride 5 mg/1

Manufacturer
Medcore LLC

Identifiers & Regulatory

Product NDC 82461-714
Product ID 82461-714_24fbbff2-fec1-4884-8dfc-1d19a20d5f0d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208170
Listing Expiration 2027-12-31
Marketing Start 2026-01-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82461714
Hyphenated Format 82461-714

Supplemental Identifiers

RxCUI
828320 828348
UPC
0382461714901 0382461716905
UNII
0VE05JYS2P

Packaging Origin

Original Packager
true

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 ANDA208170 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE (82461-714-90)
source: ndc

Packages (1)

82461-714-90 90 TABLET, FILM COATED in 1 BOTTLE (82461-714-90)

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": "24fbbff2-fec1-4884-8dfc-1d19a20d5f0d", "openfda": {"upc": ["0382461714901", "0382461716905"], "unii": ["0VE05JYS2P"], "rxcui": ["828320", "828348"], "spl_set_id": ["1b834bd5-9ee6-42a4-819c-5c605fd18e1f"], "manufacturer_name": ["Medcore LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (82461-714-90)", "package_ndc": "82461-714-90", "marketing_start_date": "20260111"}], "brand_name": "CYCLOBENZAPRINE HYDROCHLORIDE", "product_id": "82461-714_24fbbff2-fec1-4884-8dfc-1d19a20d5f0d", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "82461-714", "generic_name": "cyclobenzaprine hydrochloride", "labeler_name": "Medcore LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CYCLOBENZAPRINE HYDROCHLORIDE", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA208170", "marketing_category": "ANDA", "marketing_start_date": "20260111", "listing_expiration_date": "20271231"}