NDC 21695-997

Lactulose

Lactulose

Lactulose is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Lactulose.

Product ID21695-997_a61e6ba8-b342-4815-9623-eb0c319ecc74
NDC21695-997
Product TypeHuman Prescription Drug
Proprietary NameLactulose
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2004-04-19
Marketing CategoryANDA / ANDA
Application NumberANDA074623
Labeler NameRebel Distributors Corp
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 FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-997-32

946 mL in 1 BOTTLE (21695-997-32)
Marketing Start Date2004-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-997-32 [21695099732]

Lactulose SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2004-04-19
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/15mL

OpenFDA Data

SPL SET ID:a61e6ba8-b342-4815-9623-eb0c319ecc74
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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