metaxalone

Generic: metaxalone

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler a-s medication solutions
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 800 mg/1

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-3650
Product ID 50090-3650_8d2d65ad-3146-4218-8373-539cf48d3fe2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204770
Listing Expiration 2026-12-31
Marketing Start 2016-11-22

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 500903650
Hyphenated Format 50090-3650

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 ANDA204770 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (50090-3650-0)
  • 60 TABLET in 1 BOTTLE (50090-3650-1)
  • 15 TABLET in 1 BOTTLE, PLASTIC (50090-3650-2)
  • 20 TABLET in 1 BOTTLE, PLASTIC (50090-3650-3)
  • 10 TABLET in 1 BOTTLE, PLASTIC (50090-3650-4)
  • 100 TABLET in 1 BOTTLE (50090-3650-5)
source: ndc

Packages (6)

50090-3650-0 30 TABLET in 1 BOTTLE (50090-3650-0) 50090-3650-1 60 TABLET in 1 BOTTLE (50090-3650-1) 50090-3650-2 15 TABLET in 1 BOTTLE, PLASTIC (50090-3650-2) 50090-3650-3 20 TABLET in 1 BOTTLE, PLASTIC (50090-3650-3) 50090-3650-4 10 TABLET in 1 BOTTLE, PLASTIC (50090-3650-4) 50090-3650-5 100 TABLET in 1 BOTTLE (50090-3650-5)

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": "8d2d65ad-3146-4218-8373-539cf48d3fe2", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["d4caa7c6-afb5-43a2-ba38-cf30106b1d62"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (50090-3650-0)", "package_ndc": "50090-3650-0", "marketing_start_date": "20181011"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (50090-3650-1)", "package_ndc": "50090-3650-1", "marketing_start_date": "20181011"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (50090-3650-2)", "package_ndc": "50090-3650-2", "marketing_start_date": "20161122"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE, PLASTIC (50090-3650-3)", "package_ndc": "50090-3650-3", "marketing_start_date": "20161122"}, {"sample": false, "description": "10 TABLET in 1 BOTTLE, PLASTIC (50090-3650-4)", "package_ndc": "50090-3650-4", "marketing_start_date": "20161122"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (50090-3650-5)", "package_ndc": "50090-3650-5", "marketing_start_date": "20181018"}], "brand_name": "Metaxalone", "product_id": "50090-3650_8d2d65ad-3146-4218-8373-539cf48d3fe2", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "50090-3650", "generic_name": "Metaxalone", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "800 mg/1"}], "application_number": "ANDA204770", "marketing_category": "ANDA", "marketing_start_date": "20161122", "listing_expiration_date": "20261231"}