NDC 66689-038

LACTULOSE

Lactulose

LACTULOSE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Vistapharm, Inc.. The primary component is Lactulose.

Product ID66689-038_4bead912-29de-4a1b-a6e5-049990053554
NDC66689-038
Product TypeHuman Prescription Drug
Proprietary NameLACTULOSE
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2010-05-10
Marketing CategoryANDA / ANDA
Application NumberANDA074138
Labeler NameVistaPharm, Inc.
Substance NameLACTULOSE
Active Ingredient Strength20 g/30mL
Pharm ClassesOsmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 66689-038-50

5 TRAY in 1 CASE (66689-038-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE (66689-038-01)
Marketing Start Date2010-05-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 66689-038-01 [66689003801]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074138
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-05-10

NDC 66689-038-50 [66689003850]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074138
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2010-05-10

NDC 66689-038-99 [66689003899]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-05-10

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE20 g/30mL

OpenFDA Data

SPL SET ID:7016bd71-c667-46fc-8c56-5023682e8bbe
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 391937
  • 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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