metaxalone

Generic: metaxalone

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metaxalone 800 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6831
Product ID 0904-6831_6c542137-1ac8-4d4e-bca2-16ec8827d59e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207466
Listing Expiration 2026-12-31
Marketing Start 2017-08-31

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 09046831
Hyphenated Format 0904-6831

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 ANDA207466 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 30 BLISTER PACK in 1 CARTON (0904-6831-04) / 1 TABLET in 1 BLISTER PACK
  • 50 BLISTER PACK in 1 CARTON (0904-6831-06) / 1 TABLET in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6831-04 30 BLISTER PACK in 1 CARTON (0904-6831-04) / 1 TABLET in 1 BLISTER PACK 0904-6831-06 50 BLISTER PACK in 1 CARTON (0904-6831-06) / 1 TABLET in 1 BLISTER PACK

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": "6c542137-1ac8-4d4e-bca2-16ec8827d59e", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["8c1e10fe-0330-4bf8-a94d-aeed80f6aef1"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "30 BLISTER PACK in 1 CARTON (0904-6831-04)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6831-04", "marketing_start_date": "20170831"}, {"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6831-06)  / 1 TABLET in 1 BLISTER PACK", "package_ndc": "0904-6831-06", "marketing_start_date": "20170831"}], "brand_name": "Metaxalone", "product_id": "0904-6831_6c542137-1ac8-4d4e-bca2-16ec8827d59e", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0904-6831", "generic_name": "Metaxalone", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "800 mg/1"}], "application_number": "ANDA207466", "marketing_category": "ANDA", "marketing_start_date": "20170831", "listing_expiration_date": "20261231"}