NDC 50383-779

Lactulose

Lactulose

Lactulose is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Hi-tech Pharmacal Co., Inc.. The primary component is Lactulose.

Product ID50383-779_2a039f04-91df-492f-ab04-f9b85d1f3caa
NDC50383-779
Product TypeHuman Prescription Drug
Proprietary NameLactulose
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1995-07-03
Marketing CategoryANDA / ANDA
Application NumberANDA074076
Labeler NameHi-Tech Pharmacal Co., Inc.
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 Through2020-12-31

Packaging

NDC 50383-779-08

237 mL in 1 BOTTLE (50383-779-08)
Marketing Start Date1995-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50383-779-32 [50383077932]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-07-03

NDC 50383-779-08 [50383077908]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-07-03

NDC 50383-779-16 [50383077916]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-07-03

NDC 50383-779-33 [50383077933]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-04

NDC 50383-779-15 [50383077915]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-07-03

NDC 50383-779-30 [50383077930]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-07-03

NDC 50383-779-17 [50383077917]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-04

NDC 50383-779-31 [50383077931]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2009-09-04

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/15mL

OpenFDA Data

SPL SET ID:19455240-16b6-4e25-a5c9-a6c965e5ec19
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]
    • Osmotic Laxative [EPC]
    • Osmotic Activity [MoA]
    • Acidifying Activity [MoA]
    • Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

    Medicade Reported Pricing

    50383077932 LACTULOSE 10 GM/15 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    50383077916 LACTULOSE 10 GM/15 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    50383077908 LACTULOSE 10 GM/15 ML SOLUTION

    Pricing Unit: ML | Drug Type:

    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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