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 400 mg/1

Manufacturer
Amneal Pharmaceuticals of New York LLC

Identifiers & Regulatory

Product NDC 0115-1745
Product ID 0115-1745_3bbe28a7-6fc1-4bd0-aea7-f64a98878335
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA040486
Listing Expiration 2026-12-31
Marketing Start 2016-05-26

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 01151745
Hyphenated Format 0115-1745

Supplemental Identifiers

RxCUI
197935
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 ANDA040486 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0115-1745-01)
source: ndc

Packages (1)

0115-1745-01 100 TABLET in 1 BOTTLE (0115-1745-01)

Ingredients (1)

metaxalone (400 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": "3bbe28a7-6fc1-4bd0-aea7-f64a98878335", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["197935"], "spl_set_id": ["de3448df-4ca1-44ec-bad1-486549cddf64"], "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 (0115-1745-01)", "package_ndc": "0115-1745-01", "marketing_start_date": "20160526"}], "brand_name": "Metaxalone", "product_id": "0115-1745_3bbe28a7-6fc1-4bd0-aea7-f64a98878335", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0115-1745", "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": "400 mg/1"}], "application_number": "ANDA040486", "marketing_category": "ANDA", "marketing_start_date": "20160526", "listing_expiration_date": "20261231"}