0006-3841 NDC - SINGULAIR (MONTELUKAST SODIUM)

Drug Information

Product NDC: 0006-3841

Proprietary Name: SINGULAIR

Non Proprietary Name: montelukast sodium

Active Ingredient(s):
  • 4 mg/1 MONTELUKAST SODIUM


Administration Route(s): ORAL

Dosage Form(s): GRANULE

Pharmacy Class(es):
  • Leukotriene Receptor Antagonist [EPC];
  • Leukotriene Receptor Antagonists [MoA]

Labeler Information

Labeler Name: Merck Sharp & Dohme Corp.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA021409
Marketing Category: NDA
Start Marketing Date:7/26/2002

Package Information

No. Package Code Package Description Billing Unit
10006-3841-144 PACKET in 1 CARTON (0006-3841-14) > 1 GRANULE in 1 PACKET
20006-3841-3030 PACKET in 1 CARTON (0006-3841-30) > 1 GRANULE in 1 PACKETEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0006-3841The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMESINGULAIRThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEmontelukast sodiumThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGRANULEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE7/26/2002This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMENDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERNDA021409This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEMerck Sharp & Dohme Corp.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEMONTELUKAST SODIUMThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH4 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESLeukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA] 

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This page was last updated on: 3/20/2020