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, CHEWABLE
Routes
ORAL
Active Ingredients

montelukast 4 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-727
Product ID 31722-727_c503ea71-c663-3cfc-e053-2a95a90a9aaa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA204093
Listing Expiration 2026-12-31
Marketing Start 2015-05-27

Pharmacologic Class

Established (EPC)
leukotriene receptor antagonist [epc]
Mechanism of Action
leukotriene receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722727
Hyphenated Format 31722-727

Supplemental Identifiers

RxCUI
242438 311759
UPC
0331722727303 0331722728300
UNII
MHM278SD3E
NUI
N0000175777 N0000000083

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 ANDA204093 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 4 mg/1
source: ndc
Packaging
  • 100 TABLET, CHEWABLE in 1 BOTTLE (31722-727-01)
  • 1000 TABLET, CHEWABLE in 1 BOTTLE (31722-727-10)
  • 30 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30)
  • 10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-727-31)
  • 100 TABLET, CHEWABLE in 1 CARTON (31722-727-32)
  • 90 TABLET, CHEWABLE in 1 BOTTLE (31722-727-90)
source: ndc

Packages (6)

31722-727-01 100 TABLET, CHEWABLE in 1 BOTTLE (31722-727-01) 31722-727-10 1000 TABLET, CHEWABLE in 1 BOTTLE (31722-727-10) 31722-727-30 30 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30) 31722-727-31 10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-727-31) 31722-727-32 100 TABLET, CHEWABLE in 1 CARTON (31722-727-32) 31722-727-90 90 TABLET, CHEWABLE in 1 BOTTLE (31722-727-90)

Ingredients (1)

montelukast (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": "c503ea71-c663-3cfc-e053-2a95a90a9aaa", "openfda": {"nui": ["N0000175777", "N0000000083"], "upc": ["0331722727303", "0331722728300"], "unii": ["MHM278SD3E"], "rxcui": ["242438", "311759"], "spl_set_id": ["23964723-2df8-4d0a-a53d-8538469672f1"], "pharm_class_epc": ["Leukotriene Receptor Antagonist [EPC]"], "pharm_class_moa": ["Leukotriene Receptor Antagonists [MoA]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET, CHEWABLE in 1 BOTTLE (31722-727-01)", "package_ndc": "31722-727-01", "marketing_start_date": "20150527"}, {"sample": false, "description": "1000 TABLET, CHEWABLE in 1 BOTTLE (31722-727-10)", "package_ndc": "31722-727-10", "marketing_start_date": "20150527"}, {"sample": false, "description": "30 TABLET, CHEWABLE in 1 BOTTLE (31722-727-30)", "package_ndc": "31722-727-30", "marketing_start_date": "20150527"}, {"sample": false, "description": "10 TABLET, CHEWABLE in 1 BLISTER PACK (31722-727-31)", "package_ndc": "31722-727-31", "marketing_start_date": "20150527"}, {"sample": false, "description": "100 TABLET, CHEWABLE in 1 CARTON (31722-727-32)", "package_ndc": "31722-727-32", "marketing_start_date": "20150527"}, {"sample": false, "description": "90 TABLET, CHEWABLE in 1 BOTTLE (31722-727-90)", "package_ndc": "31722-727-90", "marketing_start_date": "20150527"}], "brand_name": "montelukast sodium", "product_id": "31722-727_c503ea71-c663-3cfc-e053-2a95a90a9aaa", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Leukotriene Receptor Antagonist [EPC]", "Leukotriene Receptor Antagonists [MoA]"], "product_ndc": "31722-727", "generic_name": "montelukast sodium", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "montelukast sodium", "active_ingredients": [{"name": "MONTELUKAST", "strength": "4 mg/1"}], "application_number": "ANDA204093", "marketing_category": "ANDA", "marketing_start_date": "20150527", "listing_expiration_date": "20261231"}