metaxalone

Generic: metaxalone

Labeler: amneal pharmaceuticals of new york llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler amneal pharmaceuticals of new york llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 800 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 53746-553
Product ID 53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203399
Listing Expiration 2026-12-31
Marketing Start 2013-05-31

Pharmacologic Class

Established (EPC)
muscle relaxant [epc]
Physiologic Effect
centrally-mediated muscle relaxation [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 53746553
Hyphenated Format 53746-553

Supplemental Identifiers

RxCUI
351254
UPC
0353746553300
UNII
1NMA9J598Y
NUI
N0000175730 N0000175737

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 metaxalone (source: ndc)
Generic Name metaxalone (source: ndc)
Application Number ANDA203399 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (53746-553-01)
  • 500 TABLET in 1 BOTTLE (53746-553-05)
  • 30 TABLET in 1 BOTTLE (53746-553-30)
source: ndc

Packages (3)

53746-553-01 100 TABLET in 1 BOTTLE (53746-553-01) 53746-553-05 500 TABLET in 1 BOTTLE (53746-553-05) 53746-553-30 30 TABLET in 1 BOTTLE (53746-553-30)

Ingredients (1)

metaxalone (800 mg/1)

Linked Drug Pages (1)

Metaxalone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b3ba9f93-52d6-4287-9e28-92059e0bf18b", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0353746553300"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["f06f2b96-3684-483c-89f7-6c9201fd4664"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals of New York LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (53746-553-01)", "package_ndc": "53746-553-01", "marketing_start_date": "20130531"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (53746-553-05)", "package_ndc": "53746-553-05", "marketing_start_date": "20130531"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (53746-553-30)", "package_ndc": "53746-553-30", "marketing_start_date": "20130531"}], "brand_name": "Metaxalone", "product_id": "53746-553_b3ba9f93-52d6-4287-9e28-92059e0bf18b", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]"], "product_ndc": "53746-553", "generic_name": "Metaxalone", "labeler_name": "Amneal Pharmaceuticals of New York LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "800 mg/1"}], "application_number": "ANDA203399", "marketing_category": "ANDA", "marketing_start_date": "20130531", "listing_expiration_date": "20261231"}