metaxalone

Generic: metaxalone

Labeler: direct_rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metaxalone 800 mg/1

Manufacturer
Direct_Rx

Identifiers & Regulatory

Product NDC 72189-645
Product ID 72189-645_485b0bfc-d2a5-21dd-e063-6294a90a96d1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203695
Listing Expiration 2027-12-31
Marketing Start 2025-12-08

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 72189645
Hyphenated Format 72189-645

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
  • 30 TABLET in 1 BOTTLE (72189-645-30)
  • 60 TABLET in 1 BOTTLE (72189-645-60)
  • 90 TABLET in 1 BOTTLE (72189-645-90)
source: ndc

Packages (3)

72189-645-30 30 TABLET in 1 BOTTLE (72189-645-30) 72189-645-60 60 TABLET in 1 BOTTLE (72189-645-60) 72189-645-90 90 TABLET in 1 BOTTLE (72189-645-90)

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": "485b0bfc-d2a5-21dd-e063-6294a90a96d1", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["45726fbc-3450-63f7-e063-6394a90a671a"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (72189-645-30)", "package_ndc": "72189-645-30", "marketing_start_date": "20251208"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (72189-645-60)", "package_ndc": "72189-645-60", "marketing_start_date": "20251208"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (72189-645-90)", "package_ndc": "72189-645-90", "marketing_start_date": "20251208"}], "brand_name": "Metaxalone", "product_id": "72189-645_485b0bfc-d2a5-21dd-e063-6294a90a96d1", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72189-645", "generic_name": "Metaxalone", "labeler_name": "Direct_Rx", "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": "20251208", "listing_expiration_date": "20271231"}