montelukast sodium

Generic: montelukast sodium

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

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler rising pharma holdings, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Rising Pharma Holdings, Inc.

Identifiers & Regulatory

Product NDC 16571-100
Product ID 16571-100_c3c93ca9-9367-4426-b310-5507dd588b08
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209012
Listing Expiration 2026-12-31
Marketing Start 2023-06-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 16571100
Hyphenated Format 16571-100

Supplemental Identifiers

RxCUI
200224
UPC
0316571100095
UNII
U1O3J18SFL

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 montelukast sodium (source: ndc)
Generic Name montelukast sodium (source: ndc)
Application Number ANDA209012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 90 TABLET in 1 BOTTLE (16571-100-09)
  • 1000 TABLET in 1 BOTTLE (16571-100-10)
source: ndc

Packages (2)

16571-100-09 90 TABLET in 1 BOTTLE (16571-100-09) 16571-100-10 1000 TABLET in 1 BOTTLE (16571-100-10)

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": "c3c93ca9-9367-4426-b310-5507dd588b08", "openfda": {"upc": ["0316571100095"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["75723c5a-3c9e-468a-bc65-57b4c755889a"], "manufacturer_name": ["Rising Pharma Holdings, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "90 TABLET in 1 BOTTLE (16571-100-09)", "package_ndc": "16571-100-09", "marketing_start_date": "20230601"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (16571-100-10)", "package_ndc": "16571-100-10", "marketing_start_date": "20230601"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "16571-100_c3c93ca9-9367-4426-b310-5507dd588b08", "dosage_form": "TABLET", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "16571-100", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "Rising Pharma Holdings, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA209012", "marketing_category": "ANDA", "marketing_start_date": "20230601", "listing_expiration_date": "20261231"}