Generlac

Product NDC
60432-038
11-digit product format
604320038
Labeler code
60432
Product ID
60432-038_48f7403f-d257-41a6-a871-fb233c6ef8e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Morton Grove Pharmaceuticals, Inc.
Application
ANDA074603
Marketing category
ANDA
Marketing start
1996-10-31
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
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60432-038-16ML - Milliliter60432-03808acb287-1167-4215-8f20-094e9c06d29412012-07-24
60432-038-64ML - Milliliter60432-038ead49c83-ae97-4c2c-a95e-faa28e3c028c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LactuloseACTIVE INGREDIENT9U7D5QH5AEGENERLAC (LACTULOSE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3
LactuloseACTIVE MOIETY9U7D5QH5AEGENERLAC (LACTULOSE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60432-038GENERLAC (LACTULOSE) SOLUTION [MORTON GROVE PHARMACEUTICALS, INC.]6Legacy NDC20190108_2a2eee86-273e-4718-8f78-34f15e193040.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60432-038-1660432003816473 mL in 1 BOTTLE, PLASTIC (60432-038-16) 473 ml1996-10-310000-00-00NoNoCurrent
60432-038-64604320038641892 mL in 1 BOTTLE, PLASTIC (60432-038-64) 1892 ml1996-10-310000-00-00NoNoCurrent