montelukast sodium

Generic: montelukast sodium

Labeler: american health packaging
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler american health packaging
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
American Health Packaging

Identifiers & Regulatory

Product NDC 68084-875
Product ID 68084-875_25c65159-60a2-629f-e063-6394a90a917f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201582
Listing Expiration 2026-12-31
Marketing Start 2015-04-02

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68084875
Hyphenated Format 68084-875

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 ANDA201582 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-875-01) / 1 TABLET, COATED in 1 BLISTER PACK (68084-875-11)
source: ndc

Packages (1)

68084-875-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-875-01) / 1 TABLET, COATED in 1 BLISTER PACK (68084-875-11)

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": "25c65159-60a2-629f-e063-6394a90a917f", "openfda": {"unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["fb1b2e4e-a840-447b-b943-ad0b6acc32b5"], "manufacturer_name": ["American Health Packaging"]}, "finished": true, "packaging": [{"sample": false, "description": "100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-875-01)  / 1 TABLET, COATED in 1 BLISTER PACK (68084-875-11)", "package_ndc": "68084-875-01", "marketing_start_date": "20150402"}], "brand_name": "Montelukast Sodium", "product_id": "68084-875_25c65159-60a2-629f-e063-6394a90a917f", "dosage_form": "TABLET, COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "68084-875", "generic_name": "Montelukast Sodium", "labeler_name": "American Health Packaging", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA201582", "marketing_category": "ANDA", "marketing_start_date": "20150402", "listing_expiration_date": "20261231"}