montelukast

Generic: montelukast

Labeler: avpak
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast
Generic Name montelukast
Labeler avpak
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
AvPAK

Identifiers & Regulatory

Product NDC 50268-556
Product ID 50268-556_47e755f4-d852-60b7-e063-6294a90aa1e4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2027-12-31
Marketing Start 2022-02-08

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50268556
Hyphenated Format 50268-556

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
  • 50 BLISTER PACK in 1 BOX (50268-556-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-556-11)
source: ndc

Packages (1)

50268-556-15 50 BLISTER PACK in 1 BOX (50268-556-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-556-11)

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": "47e755f4-d852-60b7-e063-6294a90aa1e4", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["d7870c45-5a8b-8369-e053-2a95a90ae1f3"], "manufacturer_name": ["AvPAK"]}, "finished": true, "packaging": [{"sample": false, "description": "50 BLISTER PACK in 1 BOX (50268-556-15)  / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-556-11)", "package_ndc": "50268-556-15", "marketing_start_date": "20220208"}], "brand_name": "Montelukast", "product_id": "50268-556_47e755f4-d852-60b7-e063-6294a90aa1e4", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "50268-556", "generic_name": "Montelukast", "labeler_name": "AvPAK", "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": "20220208", "listing_expiration_date": "20271231"}