LACTULOSE

Product NDC
66689-039
11-digit product format
666890039
Labeler code
66689
Product ID
66689-039_4bead912-29de-4a1b-a6e5-049990053554
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LACTULOSE
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
ANDA074138
Marketing category
ANDA
Marketing start
2010-05-10
Marketing end
0000-00-00
Substance
LACTULOSE
Active strength
10 g/15mL
Pharmacologic classes
Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-039-502024-01-30C16284748780-11030e365-4e41-111a-e063-dadaa90a10e27016bd71-c667-46fc-8c56-5023682e8bbe

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-039-01ML - Milliliter66689-0392b7f13ad-5317-4e81-aa70-ce4a513e340f12012-07-24
66689-039-50ML - Milliliter66689-039e7f4dd82-a72b-422a-b7b4-0d4309fdcece12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LACTULOSEACTIVE INGREDIENT9U7D5QH5AELACTULOSE SOLUTION [VISTAPHARM, INC]2
LACTULOSEACTIVE MOIETY9U7D5QH5AELACTULOSE SOLUTION [VISTAPHARM, INC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8LACTULOSE SOLUTION [VISTAPHARM, INC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILACTULOSE SOLUTION [VISTAPHARM, INC]2
WATERINACTIVE INGREDIENT059QF0KO0RLACTULOSE SOLUTION [VISTAPHARM, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-039LACTULOSE SOLUTION [VISTAPHARM, LLC]7Legacy NDC20241207_7016bd71-c667-46fc-8c56-5023682e8bbe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-039-50666890039505 TRAY in 1 CASE (66689-039-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE (66689-039-01) 5 tray2010-05-100000-00-00NoNoCurrent