metaxalone

Generic: metaxalone

Labeler: remedyrepack inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name metaxalone
Generic Name metaxalone
Labeler remedyrepack inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

metaxalone 800 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-0771
Product ID 70518-0771_4836b7ef-044d-fe73-e063-6294a90ace99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204770
Listing Expiration 2027-12-31
Marketing Start 2017-10-09

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 705180771
Hyphenated Format 70518-0771

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 ANDA204770 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 800 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE, PLASTIC (70518-0771-0)
  • 30 TABLET in 1 BOTTLE, PLASTIC (70518-0771-1)
  • 120 TABLET in 1 BOTTLE, PLASTIC (70518-0771-4)
source: ndc

Packages (3)

70518-0771-0 90 TABLET in 1 BOTTLE, PLASTIC (70518-0771-0) 70518-0771-1 30 TABLET in 1 BOTTLE, PLASTIC (70518-0771-1) 70518-0771-4 120 TABLET in 1 BOTTLE, PLASTIC (70518-0771-4)

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": "4836b7ef-044d-fe73-e063-6294a90ace99", "openfda": {"nui": ["N0000175730", "N0000175737"], "unii": ["1NMA9J598Y"], "rxcui": ["351254"], "spl_set_id": ["e9e45029-b1a4-435f-b9ca-cdfa01051bc8"], "pharm_class_pe": ["Centrally-mediated Muscle Relaxation [PE]"], "pharm_class_epc": ["Muscle Relaxant [EPC]"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE, PLASTIC (70518-0771-0)", "package_ndc": "70518-0771-0", "marketing_start_date": "20171009"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE, PLASTIC (70518-0771-1)", "package_ndc": "70518-0771-1", "marketing_start_date": "20190114"}, {"sample": false, "description": "120 TABLET in 1 BOTTLE, PLASTIC (70518-0771-4)", "package_ndc": "70518-0771-4", "marketing_start_date": "20240626"}], "brand_name": "Metaxalone", "product_id": "70518-0771_4836b7ef-044d-fe73-e063-6294a90ace99", "dosage_form": "TABLET", "pharm_class": ["Centrally-mediated Muscle Relaxation [PE]", "Muscle Relaxant [EPC]"], "product_ndc": "70518-0771", "generic_name": "Metaxalone", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Metaxalone", "active_ingredients": [{"name": "METAXALONE", "strength": "800 mg/1"}], "application_number": "ANDA204770", "marketing_category": "ANDA", "marketing_start_date": "20171009", "listing_expiration_date": "20271231"}