montelukast sodium

Generic: montelukast sodium

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name montelukast sodium
Generic Name montelukast sodium
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

montelukast sodium 10 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-726
Product ID 31722-726_30387eb8-222d-146e-e063-6294a90a12a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA202843
Listing Expiration 2026-12-31
Marketing Start 2014-09-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722726
Hyphenated Format 31722-726

Supplemental Identifiers

RxCUI
200224
UPC
0331722726306
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 ANDA202843 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10)
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-726-30)
  • 10 BLISTER PACK in 1 CARTON (31722-726-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-726-90)
source: ndc

Packages (5)

31722-726-01 100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01) 31722-726-10 1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10) 31722-726-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-726-30) 31722-726-32 10 BLISTER PACK in 1 CARTON (31722-726-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31) 31722-726-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-726-90)

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": "30387eb8-222d-146e-e063-6294a90a12a7", "openfda": {"upc": ["0331722726306"], "unii": ["U1O3J18SFL"], "rxcui": ["200224"], "spl_set_id": ["97a682c2-7e00-4d07-a5ac-4436c977f842"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, FILM COATED in 1 BOTTLE (31722-726-01)", "package_ndc": "31722-726-01", "marketing_start_date": "20140910"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (31722-726-10)", "package_ndc": "31722-726-10", "marketing_start_date": "20140910"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-726-30)", "package_ndc": "31722-726-30", "marketing_start_date": "20140910"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-726-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-726-31)", "package_ndc": "31722-726-32", "marketing_start_date": "20140910"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-726-90)", "package_ndc": "31722-726-90", "marketing_start_date": "20140910"}], "brand_name": "MONTELUKAST SODIUM", "product_id": "31722-726_30387eb8-222d-146e-e063-6294a90a12a7", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "31722-726", "generic_name": "MONTELUKAST SODIUM", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "MONTELUKAST SODIUM", "active_ingredients": [{"name": "MONTELUKAST SODIUM", "strength": "10 mg/1"}], "application_number": "ANDA202843", "marketing_category": "ANDA", "marketing_start_date": "20140910", "listing_expiration_date": "20261231"}