Lactulose

Product NDC
13668-580
11-digit product format
136680580
Labeler code
13668
Product ID
13668-580_dee4434b-26bd-4360-e053-2a95a90a6bb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lactulose
Dosage form
SOLUTION
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA207786
Marketing category
ANDA
Marketing start
2018-10-15
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-580-08ML - Milliliter13668-580eb4041e4-c846-478f-8c96-aec956b058c312018-12-13
13668-580-10ML - Milliliter13668-5804e54c57f-58c7-4019-8758-44e4983c935b12018-12-13
13668-580-12ML - Milliliter13668-580001bd138-d1b5-4082-901e-8462046b627a12018-12-13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-580-0813668058008237 mL in 1 BOTTLE (13668-580-08) 237 ml2018-10-150000-00-00NoNoCurrent
13668-580-1013668058010473 mL in 1 BOTTLE (13668-580-10) 473 ml2018-10-150000-00-00NoNoCurrent
13668-580-1213668058012946 mL in 1 BOTTLE (13668-580-12) 946 ml2018-10-150000-00-00NoNoCurrent