metaxalone

Generic: metaxalone

Labeler: asclemed usa, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler asclemed usa, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 800 mg/1

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-898
Product ID 76420-898_3507d3aa-6c7f-962d-e063-6294a90ae333
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203695
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

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 76420898
Hyphenated Format 76420-898

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 ANDA203695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (76420-898-01)
  • 12 TABLET in 1 BOTTLE (76420-898-12)
  • 15 TABLET in 1 BOTTLE (76420-898-15)
  • 20 TABLET in 1 BOTTLE (76420-898-20)
  • 30 TABLET in 1 BOTTLE (76420-898-30)
  • 60 TABLET in 1 BOTTLE (76420-898-60)
  • 90 TABLET in 1 BOTTLE (76420-898-90)
source: ndc

Packages (7)

76420-898-01 100 TABLET in 1 BOTTLE (76420-898-01) 76420-898-12 12 TABLET in 1 BOTTLE (76420-898-12) 76420-898-15 15 TABLET in 1 BOTTLE (76420-898-15) 76420-898-20 20 TABLET in 1 BOTTLE (76420-898-20) 76420-898-30 30 TABLET in 1 BOTTLE (76420-898-30) 76420-898-60 60 TABLET in 1 BOTTLE (76420-898-60) 76420-898-90 90 TABLET in 1 BOTTLE (76420-898-90)

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": "3507d3aa-6c7f-962d-e063-6294a90ae333", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["f4a0e910-2b20-46d4-b49e-21fb15925b58"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (76420-898-01)", "package_ndc": "76420-898-01", "marketing_start_date": "20250110"}, {"sample": false, "description": "12 TABLET in 1 BOTTLE (76420-898-12)", "package_ndc": "76420-898-12", "marketing_start_date": "20250513"}, {"sample": false, "description": "15 TABLET in 1 BOTTLE (76420-898-15)", "package_ndc": "76420-898-15", "marketing_start_date": "20250110"}, {"sample": false, "description": "20 TABLET in 1 BOTTLE (76420-898-20)", "package_ndc": "76420-898-20", "marketing_start_date": "20250110"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (76420-898-30)", "package_ndc": "76420-898-30", "marketing_start_date": "20250110"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (76420-898-60)", "package_ndc": "76420-898-60", "marketing_start_date": "20250110"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (76420-898-90)", "package_ndc": "76420-898-90", "marketing_start_date": "20250110"}], "brand_name": "Metaxalone", "product_id": "76420-898_3507d3aa-6c7f-962d-e063-6294a90ae333", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "76420-898", "generic_name": "Metaxalone", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "800 mg/1"}], "application_number": "ANDA203695", "marketing_category": "ANDA", "marketing_start_date": "20170619", "listing_expiration_date": "20261231"}