NDC 0121-4577

LACTULOSE

Lactulose

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

Product ID0121-4577_8371b14b-382d-c5c4-e053-2991aa0a8675
NDC0121-4577
Product TypeHuman Prescription Drug
Proprietary NameLACTULOSE
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date1966-07-30
Marketing CategoryANDA / ANDA
Application NumberANDA074623
Labeler NamePharmaceutical Associates
Substance NameLACTULOSE
Active Ingredient Strength10 g/15mL
Pharm ClassesOsmotic Laxativ
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0121-4577-06

6 CARTON in 1 CASE (0121-4577-06) > 16 CUP, UNIT-DOSE in 1 CARTON > 15 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2019-05-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-4577-30 [00121457730]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1966-07-30
Marketing End Date2020-01-20

NDC 0121-4577-15 [00121457715]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1966-07-30

NDC 0121-4577-40 [00121457740]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1966-07-30

NDC 0121-4577-06 [00121457706]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-05-03

NDC 0121-4577-35 [00121457735]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1966-07-30
Marketing End Date2020-01-20

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE10 g/15mL

OpenFDA Data

SPL SET ID:0f19e4ed-c90a-4330-a7fa-bf911aa98f09
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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