cyclobenzaprine hydrochloride

Generic: cyclobenzaprine hydrochloride

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name cyclobenzaprine hydrochloride
Generic Name cyclobenzaprine hydrochloride
Labeler amneal pharmaceuticals of new york llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 15 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1436
Product ID 0115-1436_8e7da23f-dda8-4834-91ae-0691668d1374
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2019-03-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01151436
Hyphenated Format 0115-1436

Supplemental Identifiers

RxCUI
828353 828358
UPC
0301151437135 0301151436138
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 NDA021777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 15 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1436-13)
source: ndc

Packages (1)

0115-1436-13 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1436-13)

Ingredients (1)

cyclobenzaprine hydrochloride (15 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": "8e7da23f-dda8-4834-91ae-0691668d1374", "openfda": {"upc": ["0301151437135", "0301151436138"], "unii": ["0VE05JYS2P"], "rxcui": ["828353", "828358"], "spl_set_id": ["dd546a0e-e5be-4232-8ad8-fcd7d5f9a903"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1436-13)", "package_ndc": "0115-1436-13", "marketing_start_date": "20190301"}], "brand_name": "Cyclobenzaprine Hydrochloride", "product_id": "0115-1436_8e7da23f-dda8-4834-91ae-0691668d1374", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0115-1436", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cyclobenzaprine Hydrochloride", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "15 mg/1"}], "application_number": "NDA021777", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20190301", "listing_expiration_date": "20261231"}