metaxalone

Generic: metaxalone

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler avpak
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 800 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-530
Product ID 50268-530_4481b1d7-8b54-035a-e063-6394a90ab23d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203399
Listing Expiration 2026-12-31
Marketing Start 2015-03-13

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 50268530
Hyphenated Format 50268-530

Supplemental Identifiers

RxCUI
351254
UNII
1NMA9J598Y
NUI
N0000175730 N0000175737

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
  • 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15) / 1 TABLET in 1 BLISTER PACK (50268-530-11)
source: ndc

Packages (1)

50268-530-15 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15) / 1 TABLET in 1 BLISTER PACK (50268-530-11)

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": "4481b1d7-8b54-035a-e063-6394a90ab23d", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["9b21a974-6a5a-9efb-e9de-470363217126"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-530-15)  / 1 TABLET in 1 BLISTER PACK (50268-530-11)", "package_ndc": "50268-530-15", "marketing_start_date": "20150313"}], "brand_name": "Metaxalone", "product_id": "50268-530_4481b1d7-8b54-035a-e063-6394a90ab23d", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50268-530", "generic_name": "Metaxalone", "labeler_name": "AvPAK", "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": "20150313", "listing_expiration_date": "20261231"}