metaxalone

Generic: metaxalone

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

metaxalone 800 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 72789-028
Product ID 72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a
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 72789028
Hyphenated Format 72789-028

Supplemental Identifiers

RxCUI
351254
UPC
0372789028309
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
  • 15 TABLET in 1 BOTTLE, PLASTIC (72789-028-15)
  • 30 TABLET in 1 BOTTLE, PLASTIC (72789-028-30)
source: ndc

Packages (2)

72789-028-15 15 TABLET in 1 BOTTLE, PLASTIC (72789-028-15) 72789-028-30 30 TABLET in 1 BOTTLE, PLASTIC (72789-028-30)

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": "2d58ab65-a0e3-e2a2-e063-6294a90a0e4a", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0372789028309"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["edc6ba8d-2d45-4833-8dc7-e2d4e5d72856"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "15 TABLET in 1 BOTTLE, PLASTIC (72789-028-15)", "package_ndc": "72789-028-15", "marketing_start_date": "20191119"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (72789-028-30)", "package_ndc": "72789-028-30", "marketing_start_date": "20191111"}], "brand_name": "Metaxalone", "product_id": "72789-028_2d58ab65-a0e3-e2a2-e063-6294a90a0e4a", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "72789-028", "generic_name": "Metaxalone", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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"}