NDC 66689-038

LACTULOSE

Lactulose

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

• Product ID: 66689-038_4bead912-29de-4a1b-a6e5-049990053554
• NDC: 66689-038
• Product Type: Human Prescription Drug
• Proprietary Name: LACTULOSE
• Generic Name: Lactulose
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2010-05-10
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074138
• Labeler Name: VistaPharm, Inc.
• Substance Name: LACTULOSE
• Active Ingredient Strength: 20 g/30mL
• Pharm Classes: Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 66689-038-50

5 TRAY in 1 CASE (66689-038-50) > 10 CUP, UNIT-DOSE in 1 TRAY > 30 mL in 1 CUP, UNIT-DOSE (66689-038-01)

• Marketing Start Date: 2010-05-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66689-038-01 [66689003801]

LACTULOSE SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074138
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-05-10

NDC 66689-038-50 [66689003850]

LACTULOSE SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074138
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2010-05-10

NDC 66689-038-99 [66689003899]

LACTULOSE SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074138
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2010-05-10

Drug Details

Active Ingredients

Ingredient	Strength
LACTULOSE	20 g/30mL

OpenFDA Data

• SPL SET ID: 7016bd71-c667-46fc-8c56-5023682e8bbe
• Manufacturer:
  • VistaPharm, Inc.
• UNII:
  • 9U7D5QH5AE
• 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"

NDC	Brand Name	Generic Name
0116-4005	Lactulose	Lactulose
0121-0577	LACTULOSE	LACTULOSE
0121-0873	LACTULOSE	Lactulose
0121-1154	LACTULOSE	LACTULOSE
0121-1746	LACTULOSE	LACTULOSE
0121-4577	LACTULOSE	LACTULOSE
0527-5120	LACTULOSE	LACTULOSE
0527-5125	LACTULOSE	LACTULOSE
0603-1378	Lactulose	lactulose
13668-574	Lactulose	Lactulose
13668-580	Lactulose	Lactulose
68071-1562	LACTULOSE	LACTULOSE
69067-010	Lactulose	Lactulose
17856-1378	Lactulose	Lactulose
18124-001	Lactulose	Lactulose
18124-002	Lactulose	Lactulose
21695-997	Lactulose	Lactulose
35356-754	Lactulose	Lactulose
50090-0679	Lactulose	Lactulose
50090-3381	Lactulose	Lactulose
50436-3101	Lactulose	Lactulose
50383-795	Lactulose	Lactulose
50383-779	Lactulose	Lactulose
53217-009	Lactulose	Lactulose
55154-5775	LACTULOSE	LACTULOSE
55154-9448	LACTULOSE	LACTULOSE
59741-249	Lactulose	Lactulose
60432-037	Lactulose	Lactulose
66689-039	LACTULOSE	LACTULOSE
66689-038	LACTULOSE	LACTULOSE
49999-800	Lactulose	Lactulose
62135-003	Lactulose	Lactulose