cyclobenzaprine hydrochloride (76282-283)

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride

Generic Name cyclobenzaprine

Labeler exelan pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

cyclobenzaprine hydrochloride 10 mg/1

Manufacturer

EXELAN PHARMACEUTICALS, INC.

Identifiers & Regulatory

Product NDC 76282-283

Product ID 76282-283_19cb705f-c529-4ad4-8eda-3a3fd48feca7

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090478

Listing Expiration 2026-12-31

Marketing Start 2025-04-10

Pharmacologic Class

Classes

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76282283

Hyphenated Format 76282-283

Supplemental Identifiers

RxCUI

828348

UPC

0376282283272 0376282283104 0376282283906 0376282283609

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 (source: ndc)

Application Number ANDA090478 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

10 mg/1

source: ndc

Packaging

1000 TABLET in 1 BOTTLE (76282-283-10)
180 TABLET in 1 BOTTLE (76282-283-18)
270 TABLET in 1 BOTTLE (76282-283-27)
30 TABLET in 1 BOTTLE (76282-283-30)
60 TABLET in 1 BOTTLE (76282-283-60)
90 TABLET in 1 BOTTLE (76282-283-90)

source: ndc

Packages (6)

76282-283-10 1000 TABLET in 1 BOTTLE (76282-283-10) 76282-283-18 180 TABLET in 1 BOTTLE (76282-283-18) 76282-283-27 270 TABLET in 1 BOTTLE (76282-283-27) 76282-283-30 30 TABLET in 1 BOTTLE (76282-283-30) 76282-283-60 60 TABLET in 1 BOTTLE (76282-283-60) 76282-283-90 90 TABLET in 1 BOTTLE (76282-283-90)

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": "19cb705f-c529-4ad4-8eda-3a3fd48feca7", "openfda": {"upc": ["0376282283272", "0376282283104", "0376282283906", "0376282283609"], "unii": ["0VE05JYS2P"], "rxcui": ["828348"], "spl_set_id": ["cf81da00-7c6d-4477-bb70-b3c2abea177a"], "manufacturer_name": ["EXELAN PHARMACEUTICALS, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (76282-283-10)", "package_ndc": "76282-283-10", "marketing_start_date": "20250410"}, {"sample": false, "description": "180 TABLET in 1 BOTTLE (76282-283-18)", "package_ndc": "76282-283-18", "marketing_start_date": "20250410"}, {"sample": false, "description": "270 TABLET in 1 BOTTLE (76282-283-27)", "package_ndc": "76282-283-27", "marketing_start_date": "20250410"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76282-283-30)", "package_ndc": "76282-283-30", "marketing_start_date": "20250410"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76282-283-60)", "package_ndc": "76282-283-60", "marketing_start_date": "20250410"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76282-283-90)", "package_ndc": "76282-283-90", "marketing_start_date": "20250410"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "76282-283_19cb705f-c529-4ad4-8eda-3a3fd48feca7", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "76282-283", "generic_name": "Cyclobenzaprine", "labeler_name": "EXELAN PHARMACEUTICALS, INC.", "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": "20250410", "listing_expiration_date": "20261231"}