NDC 13668-580

Lactulose

Lactulose

Lactulose is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Lactulose.

Product ID13668-580_5c3dff26-e778-474b-867b-606bb7ab238f
NDC13668-580
Product TypeHuman Prescription Drug
Proprietary NameLactulose
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-10-15
Marketing CategoryANDA / ANDA
Application NumberANDA207786
Labeler NameTorrent Pharmaceuticals Limited
Substance NameLACTULOSE
Active Ingredient Strength10 g/15mL
Pharm ClassesOsmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 13668-580-08

237 mL in 1 BOTTLE (13668-580-08)
Marketing Start Date2018-10-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-580-12 [13668058012]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA207786
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-15
Inactivation Date2020-01-31

NDC 13668-580-08 [13668058008]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA207786
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-15
Inactivation Date2020-01-31

NDC 13668-580-10 [13668058010]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA207786
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/15mL

OpenFDA Data

SPL SET ID:f8e984be-e137-441e-93b8-9ae51ae4a3e5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 391937
    • UPC Code
  • 0313668580105

    • Pharmacological Class

    • Osmotic Laxative [EPC]
    • Osmotic Activity [MoA]
    • Acidifying Activity [MoA]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

    NDC Crossover Matching brand name "Lactulose" or generic name "Lactulose"

    NDCBrand NameGeneric Name
    0116-4005LactuloseLactulose
    0121-0577LACTULOSELACTULOSE
    0121-0873LACTULOSELactulose
    0121-1154LACTULOSELACTULOSE
    0121-1746LACTULOSELACTULOSE
    0121-4577LACTULOSELACTULOSE
    0527-5120LACTULOSELACTULOSE
    0527-5125LACTULOSELACTULOSE
    0603-1378Lactuloselactulose
    13668-574LactuloseLactulose
    13668-580LactuloseLactulose
    68071-1562LACTULOSELACTULOSE
    69067-010LactuloseLactulose
    17856-1378LactuloseLactulose
    18124-001LactuloseLactulose
    18124-002LactuloseLactulose
    21695-997LactuloseLactulose
    35356-754LactuloseLactulose
    50090-0679LactuloseLactulose
    50090-3381LactuloseLactulose
    50436-3101LactuloseLactulose
    50383-795LactuloseLactulose
    50383-779LactuloseLactulose
    53217-009LactuloseLactulose
    55154-5775LACTULOSELACTULOSE
    55154-9448LACTULOSELACTULOSE
    59741-249LactuloseLactulose
    60432-037LactuloseLactulose
    66689-039LACTULOSELACTULOSE
    66689-038LACTULOSELACTULOSE
    49999-800LactuloseLactulose
    62135-003LactuloseLactulose
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