NDC 70436-003

Lactulose Solution

Lactulose Solution

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

Product ID70436-003_6f6e1fd5-b789-489d-a683-bd8b55965ed0
NDC70436-003
Product TypeHuman Prescription Drug
Proprietary NameLactulose Solution
Generic NameLactulose Solution
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-04-01
Marketing CategoryANDA / ANDA
Application NumberANDA209517
Labeler NameSlate Run Pharmaceuticals LLC
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 70436-003-10

100 mL in 1 BOTTLE (70436-003-10)
Marketing Start Date2019-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70436-003-14 [70436000314]

Lactulose Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Inactivation Date2020-01-31

NDC 70436-003-18 [70436000318]

Lactulose Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Inactivation Date2020-01-31

NDC 70436-003-11 [70436000311]

Lactulose Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Inactivation Date2020-01-31

NDC 70436-003-10 [70436000310]

Lactulose Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Inactivation Date2020-01-31

NDC 70436-003-13 [70436000313]

Lactulose Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Inactivation Date2020-01-31

NDC 70436-003-16 [70436000316]

Lactulose Solution SOLUTION
Marketing CategoryANDA
Application NumberANDA209517
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/15mL

OpenFDA Data

SPL SET ID:6f6e1fd5-b789-489d-a683-bd8b55965ed0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 391937
  • UPC Code
  • 0370436003143
  • 0370436003181
  • 0370436003105
  • 0370436003167
  • 0370436003112
  • 0370436003136
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    61037-471Lactulose SolutionLactulose Solution USP, 10 g/15 mL
    70436-003Lactulose SolutionLactulose Solution
    80432-001Lactulose SolutionLactulose Solution

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