metaxalone

Generic: metaxalone

Labeler: misemer pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler misemer pharmaceuticals, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 400 mg/1

Manufacturer
Misemer Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0276-0508
Product ID 0276-0508_105c4456-677d-c76a-e063-6294a90a80a4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207466
Listing Expiration 2026-12-31
Marketing Start 2021-11-01

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 02760508
Hyphenated Format 0276-0508

Supplemental Identifiers

RxCUI
197935
UPC
0302760508100
UNII
1NMA9J598Y
NUI
N0000175730 N0000175737

Packaging Origin

Original Packager
true

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
  • 400 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0276-0508-10)
source: ndc

Packages (1)

0276-0508-10 100 TABLET in 1 BOTTLE (0276-0508-10)

Ingredients (1)

metaxalone (400 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": "105c4456-677d-c76a-e063-6294a90a80a4", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0302760508100"], "unii": ["1NMA9J598Y"], "rxcui": ["197935"], "spl_set_id": ["d0276e7b-a1c9-61f3-e053-2a95a90ae3aa"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Misemer Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0276-0508-10)", "package_ndc": "0276-0508-10", "marketing_start_date": "20211101"}], "brand_name": "Metaxalone", "product_id": "0276-0508_105c4456-677d-c76a-e063-6294a90a80a4", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0276-0508", "generic_name": "Metaxalone", "labeler_name": "Misemer Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "400 mg/1"}], "application_number": "ANDA207466", "marketing_category": "ANDA", "marketing_start_date": "20211101", "listing_expiration_date": "20261231"}