montelukast

Generic: montelukast

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

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler remedyrepack inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
REMEDYREPACK INC.

Identifiers & Regulatory

Product NDC 70518-3133
Product ID 70518-3133_3d57c911-aacb-9d85-e063-6394a90a3c5a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2021-06-18

Pharmacologic Class

Classes
leukotriene receptor antagonist [epc] leukotriene receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 705183133
Hyphenated Format 70518-3133

Supplemental Identifiers

RxCUI
200224
UNII
U1O3J18SFL

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 montelukast (source: ndc)
Generic Name montelukast (source: ndc)
Application Number ANDA202843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-0)
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3133-1)
  • 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-2)
source: ndc

Packages (3)

70518-3133-0 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-0) 70518-3133-1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3133-1) 70518-3133-2 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-2)

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

Montelukast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "3d57c911-aacb-9d85-e063-6394a90a3c5a", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["ecaa9b4b-5941-4af5-930c-35e9f3b2b4ba"], "manufacturer_name": ["REMEDYREPACK INC."]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-0)", "package_ndc": "70518-3133-0", "marketing_start_date": "20210618"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3133-1)", "package_ndc": "70518-3133-1", "marketing_start_date": "20210701"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3133-2)", "package_ndc": "70518-3133-2", "marketing_start_date": "20250827"}], "brand_name": "Montelukast", "product_id": "70518-3133_3d57c911-aacb-9d85-e063-6394a90a3c5a", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "70518-3133", "generic_name": "Montelukast", "labeler_name": "REMEDYREPACK INC.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202843", "marketing_category": "ANDA", "marketing_start_date": "20210618", "listing_expiration_date": "20261231"}