NDC 0006-9117

SINGULAIR

Montelukast Sodium

SINGULAIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Montelukast Sodium.

• Product ID: 0006-9117_3e36d81d-c9c5-4e58-b359-dc5f166f85c1
• NDC: 0006-9117
• Product Type: Human Prescription Drug
• Proprietary Name: SINGULAIR
• Generic Name: Montelukast Sodium
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1998-02-20
• Marketing Category: NDA / NDA
• Application Number: NDA020829
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: MONTELUKAST SODIUM
• Active Ingredient Strength: 10 mg/1
• Pharm Classes: Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0006-9117-31

30 TABLET, FILM COATED in 1 BOTTLE (0006-9117-31)

• Marketing Start Date: 1998-02-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0006-9117-31 [00006911731]

SINGULAIR TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020829
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-02-20

NDC 0006-9117-54 [00006911754]

SINGULAIR TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020829
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-02-20

NDC 0006-9117-80 [00006911780]

SINGULAIR TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020829
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-02-20
• Marketing End Date: 2015-06-30

Drug Details

Active Ingredients

Ingredient	Strength
MONTELUKAST SODIUM	10 mg/1

OpenFDA Data

• SPL SET ID: 8c166755-7711-4df9-d689-8836a1a70885
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • U1O3J18SFL
• RxNorm Concept Unique ID - RxCUI:
  • 404406
  • 153892
  • 311759
  • 153893
  • 261367
  • 351246
  • 200224
  • 242438
• UPC Code:
  • 0300061711311
  • 0300069275310
  • 0300069117313

Pharmacological Class

• Leukotriene Receptor Antagonist [EPC]
• Leukotriene Receptor Antagonists [MoA]

NDC Crossover Matching brand name "SINGULAIR" or generic name "Montelukast Sodium"

NDC	Brand Name	Generic Name
0006-1711	SINGULAIR	montelukast sodium
0006-3841	SINGULAIR	montelukast sodium
0006-9117	SINGULAIR	montelukast sodium
0006-9275	SINGULAIR	montelukast sodium
68258-3033	SINGULAIR	SINGULAIR
68258-3032	SINGULAIR	SINGULAIR
21695-221	SINGULAIR	SINGULAIR
21695-565	SINGULAIR	SINGULAIR
63629-2979	SINGULAIR	SINGULAIR
63629-3701	SINGULAIR	SINGULAIR
0054-0259	Montelukast Sodium	Montelukast Sodium
0054-0288	Montelukast Sodium	Montelukast Sodium
0054-0289	Montelukast Sodium	Montelukast Sodium
0093-7424	Montelukast Sodium	Montelukast Sodium
0093-7425	Montelukast Sodium	Montelukast Sodium