Lactulose

Product NDC
13668-574
11-digit product format
136680574
Labeler code
13668
Product ID
13668-574_df4bb28b-5d74-2d55-e053-2995a90afc6f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL; RECTAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA203762
Marketing category
ANDA
Marketing start
2018-06-14
Marketing end
0000-00-00
Substance
LACTULOSE
Active strength
10 g/15mL
Pharmacologic classes
Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-574-08ML - Milliliter13668-5744fadd2c7-5a02-49e0-874c-adffa85dbbe312018-08-13
13668-574-10ML - Milliliter13668-574c5659bce-89de-42d9-9220-4474b9ff2ce112018-08-13
13668-574-12ML - Milliliter13668-5743393344d-253d-4aa0-b20e-9abf310a5c7b12018-08-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-574-0813668057408237 mL in 1 BOTTLE (13668-574-08) 237 ml2018-06-140000-00-00NoNoCurrent
13668-574-1013668057410473 mL in 1 BOTTLE (13668-574-10) 473 ml2018-06-140000-00-00NoNoCurrent
13668-574-1213668057412946 mL in 1 BOTTLE (13668-574-12) 946 ml2018-06-140000-00-00NoNoCurrent