metaxalone

Generic: metaxalone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler actavis pharma, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 800 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-2341
Product ID 0591-2341_ca4c1e06-87e3-4f44-aeac-3da9d4b901d3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203695
Listing Expiration 2026-12-31
Marketing Start 2017-06-19

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 05912341
Hyphenated Format 0591-2341

Supplemental Identifiers

RxCUI
351254
UPC
0305912341013
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 ANDA203695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (0591-2341-01)
source: ndc

Packages (1)

0591-2341-01 100 TABLET in 1 BOTTLE (0591-2341-01)

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": "ca4c1e06-87e3-4f44-aeac-3da9d4b901d3", "openfda": {"nui": ["N0000175730", "N0000175737"], "upc": ["0305912341013"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["b3a4f6bc-abd4-4b8e-970f-59b3aa6f17a0"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (0591-2341-01)", "package_ndc": "0591-2341-01", "marketing_start_date": "20170619"}], "brand_name": "Metaxalone", "product_id": "0591-2341_ca4c1e06-87e3-4f44-aeac-3da9d4b901d3", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "0591-2341", "generic_name": "Metaxalone", "labeler_name": "Actavis Pharma, Inc.", "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": "20170619", "listing_expiration_date": "20261231"}