NDC 0121-1746

LACTULOSE

Lactulose

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

Product ID0121-1746_9959dc27-9793-40d4-e053-2a95a90abdcd
NDC0121-1746
Product TypeHuman Prescription Drug
Proprietary NameLACTULOSE
Generic NameLactulose
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-12-03
Marketing CategoryANDA / ANDA
Application NumberANDA074623
Labeler NamePharmaceutical Associates, Inc.
Substance NameLACTULOSE
Active Ingredient Strength20 g/30mL
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 0121-1746-00

10 TRAY in 1 CASE (0121-1746-00) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2019-12-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0121-1746-00 [00121174600]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-03

NDC 0121-1746-06 [00121174606]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-03

NDC 0121-1746-30 [00121174630]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-03

NDC 0121-1746-40 [00121174640]

LACTULOSE SOLUTION
Marketing CategoryANDA
Application NumberANDA074623
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-03

Drug Details

Active Ingredients

IngredientStrength
LACTULOSE20 g/30mL

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]

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.