amrix

Generic: cyclobenzaprine hydrochloride

Labeler: cephalon, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name amrix
Generic Name cyclobenzaprine hydrochloride
Labeler cephalon, llc
Dosage Form CAPSULE, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

cyclobenzaprine hydrochloride 30 mg/1

Manufacturer
Cephalon, LLC

Identifiers & Regulatory

Product NDC 63459-701
Product ID 63459-701_ff33280b-7ccc-4a2e-bafd-cbc89cb1cee2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA021777
Listing Expiration 2026-12-31
Marketing Start 2007-10-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63459701
Hyphenated Format 63459-701

Supplemental Identifiers

RxCUI
828353 828355 828358 828359
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 amrix (source: ndc)
Generic Name cyclobenzaprine hydrochloride (source: ndc)
Application Number NDA021777 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 30 mg/1
source: ndc
Packaging
  • 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-701-60)
source: ndc

Packages (1)

63459-701-60 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-701-60)

Ingredients (1)

cyclobenzaprine hydrochloride (30 mg/1)

Linked Drug Pages (1)

AMRIX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "ff33280b-7ccc-4a2e-bafd-cbc89cb1cee2", "openfda": {"unii": ["0VE05JYS2P"], "rxcui": ["828353", "828355", "828358", "828359"], "spl_set_id": ["3902123b-1365-ac3c-0934-afff9eeeb1bd"], "manufacturer_name": ["Cephalon, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63459-701-60)", "package_ndc": "63459-701-60", "marketing_start_date": "20071101"}], "brand_name": "AMRIX", "product_id": "63459-701_ff33280b-7ccc-4a2e-bafd-cbc89cb1cee2", "dosage_form": "CAPSULE, EXTENDED RELEASE", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "63459-701", "generic_name": "Cyclobenzaprine Hydrochloride", "labeler_name": "Cephalon, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AMRIX", "active_ingredients": [{"name": "CYCLOBENZAPRINE HYDROCHLORIDE", "strength": "30 mg/1"}], "application_number": "NDA021777", "marketing_category": "NDA", "marketing_start_date": "20071001", "listing_expiration_date": "20261231"}