metaxalone

Generic: metaxalone

Labeler: ina pharmaceutics inc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler ina pharmaceutics inc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 640 mg/1

Manufacturer
INA Pharmaceutics Inc

Identifiers & Regulatory

Product NDC 74157-018
Product ID 74157-018_4a02d857-976b-b4c7-e063-6294a90a655b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022503
Listing Expiration 2027-12-31
Marketing Start 2025-02-10

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 74157018
Hyphenated Format 74157-018

Supplemental Identifiers

RxCUI
2627781
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 NDA022503 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 640 mg/1
source: ndc
Packaging
  • 60 TABLET in 1 BOTTLE (74157-018-60)
source: ndc

Packages (1)

74157-018-60 60 TABLET in 1 BOTTLE (74157-018-60)

Ingredients (1)

metaxalone (640 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": "4a02d857-976b-b4c7-e063-6294a90a655b", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["2627781"], "spl_set_id": ["fc6de1a6-26aa-47ac-a5d2-bf127a6ca563"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["INA Pharmaceutics Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (74157-018-60)", "package_ndc": "74157-018-60", "marketing_start_date": "20250210"}], "brand_name": "Metaxalone", "product_id": "74157-018_4a02d857-976b-b4c7-e063-6294a90a655b", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "74157-018", "generic_name": "Metaxalone", "labeler_name": "INA Pharmaceutics Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "640 mg/1"}], "application_number": "NDA022503", "marketing_category": "NDA", "marketing_start_date": "20250210", "listing_expiration_date": "20271231"}