montelukast sodium

Generic: montelukast sodium

Labeler: pd-rx pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler pd-rx pharmaceuticals, inc.
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/1

Manufacturer
PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-381
Product ID 43063-381_39f91bbd-3f5b-5634-e063-6394a90a5bfb
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090984
Listing Expiration 2026-12-31
Marketing Start 2012-08-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43063381
Hyphenated Format 43063-381

Supplemental Identifiers

RxCUI
311759
UPC
0343063381304
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 ANDA090984 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21)
  • 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30)
source: ndc

Packages (2)

43063-381-21 21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21) 43063-381-30 30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30)

Ingredients (1)

montelukast sodium (4 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": "39f91bbd-3f5b-5634-e063-6394a90a5bfb", "openfda": {"upc": ["0343063381304"], "unii": ["U1O3J18SFL"], "rxcui": ["311759"], "spl_set_id": ["c69ab399-8ea6-4002-9271-b6a57c862b14"], "manufacturer_name": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "21 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-21)", "package_ndc": "43063-381-21", "marketing_start_date": "20151105"}, {"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (43063-381-30)", "package_ndc": "43063-381-30", "marketing_start_date": "20151105"}], "brand_name": "Montelukast Sodium", "product_id": "43063-381_39f91bbd-3f5b-5634-e063-6394a90a5bfb", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "43063-381", "generic_name": "Montelukast Sodium", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/1"}], "application_number": "ANDA090984", "marketing_category": "ANDA", "marketing_start_date": "20120803", "listing_expiration_date": "20261231"}