montelukast sodium

Generic: montelukast sodium

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler torrent pharmaceuticals limited
Dosage Form GRANULE
Routes
ORAL
Active Ingredients

montelukast sodium 4 mg/500mg

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-531
Product ID 13668-531_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210431
Listing Expiration 2027-12-31
Marketing Start 2017-03-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668531
Hyphenated Format 13668-531

Supplemental Identifiers

RxCUI
200224 242438 311759 351246
UPC
0313668079302
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 ANDA210431 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/500mg
source: ndc
Packaging
  • 30 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11)
source: ndc

Packages (1)

13668-531-94 30 PACKET in 1 CARTON (13668-531-94) / 500 mg in 1 PACKET (13668-531-11)

Ingredients (1)

montelukast sodium (4 mg/500mg)

Linked Drug Pages (1)

Montelukast Sodium ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "64b8ff68-7440-43b9-bf2c-4e04e85b2a6a", "openfda": {"upc": ["0313668079302"], "unii": ["U1O3J18SFL"], "rxcui": ["200224", "242438", "311759", "351246"], "spl_set_id": ["da038cf6-cfad-43a4-ab8e-d81d028d6087"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 PACKET in 1 CARTON (13668-531-94)  / 500 mg in 1 PACKET (13668-531-11)", "package_ndc": "13668-531-94", "marketing_start_date": "20170330"}], "brand_name": "Montelukast Sodium", "product_id": "13668-531_64b8ff68-7440-43b9-bf2c-4e04e85b2a6a", "dosage_form": "GRANULE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "13668-531", "generic_name": "Montelukast Sodium", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Montelukast Sodium", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "4 mg/500mg"}], "application_number": "ANDA210431", "marketing_category": "ANDA", "marketing_start_date": "20170330", "listing_expiration_date": "20271231"}