montelukast sodium

Generic: montelukast sodium

Labeler: major pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler major pharmaceuticals
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-6808
Product ID 0904-6808_4a289de2-d2e7-416d-9168-7f79cbff500b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2014-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09046808
Hyphenated Format 0904-6808

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

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 50 BLISTER PACK in 1 CARTON (0904-6808-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK
  • 100 BLISTER PACK in 1 CARTON (0904-6808-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

0904-6808-06 50 BLISTER PACK in 1 CARTON (0904-6808-06) / 1 TABLET, FILM COATED in 1 BLISTER PACK 0904-6808-61 100 BLISTER PACK in 1 CARTON (0904-6808-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (1)

montelukast sodium (10 mg/1)

Linked Drug Pages (1)

Montelukast Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a289de2-d2e7-416d-9168-7f79cbff500b", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["a4dc63cf-8145-42f4-9437-93b414d2aed4"], "manufacturer_name": ["Major Pharmaceuticals"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 CARTON (0904-6808-06)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6808-06", "marketing_start_date": "20140910"}, {"sample": false, "description": "100 BLISTER PACK in 1 CARTON (0904-6808-61)  / 1 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "0904-6808-61", "marketing_start_date": "20140910"}], "brand_name": "Montelukast Sodium", "product_id": "0904-6808_4a289de2-d2e7-416d-9168-7f79cbff500b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "0904-6808", "generic_name": "Montelukast Sodium", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202843", "marketing_category": "ANDA", "marketing_start_date": "20140910", "listing_expiration_date": "20261231"}