21695-997 NDC - LACTULOSE (LACTULOSE)

Drug Information

Product NDC: 21695-997

Proprietary Name: Lactulose

Non Proprietary Name: lactulose

Active Ingredient(s):
  • 10 g/15mL LACTULOSE


Administration Route(s): ORAL

Dosage Form(s): SOLUTION

Pharmacy Class(es):
  • Osmotic Laxative [EPC];
  • Osmotic Activity [MoA];
  • Acidifying Activity [MoA];
  • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Labeler Name: Rebel Distributors Corp
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA074623
Marketing Category: ANDA
Start Marketing Date:4/19/2004

Package Information

No. Package Code Package Description Billing Unit
121695-997-32946 mL in 1 BOTTLE (21695-997-32)ML

NDC Record

Field Name Field Value Definition
PRODUCT NDC21695-997The 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 NAMELactuloseThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMElactuloseThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMESOLUTIONThe 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 DATE4/19/2004This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct 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 NUMBERANDA074623This 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 NAMERebel Distributors CorpName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELACTULOSEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10 
ACTIVE INGRED UNITg/15mL 
PHARM CLASSESOsmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE] 

Download Record

Download this NDC record in Text format: Export

Download this NDC record in Excel (CSV) format: Export

Download this NDC record in XML format: Export

This page was last updated on: 7/15/2019