NDC 53217-009

Lactulose

Lactulose

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

Product ID53217-009_9be2d0a1-1415-47de-87f0-03a66680c62f
NDC53217-009
Product TypeHuman Prescription Drug
Proprietary NameLactulose
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1995-07-03
Marketing CategoryANDA / ANDA
Application NumberANDA074076
Labeler NameAidarex 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 53217-009-01

946 mL in 1 BOTTLE, PLASTIC (53217-009-01)
Marketing Start Date1995-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-009-01 [53217000901]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074076
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1995-07-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/15mL

OpenFDA Data

SPL SET ID:a5a5747b-5194-43a9-8307-f1e05c6eacb4
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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