NDC 0603-1378

Lactulose

Lactulose

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

• Product ID: 0603-1378_018c26f5-288d-4149-83cd-e3d8bb45d8c7
• NDC: 0603-1378
• Product Type: Human Prescription Drug
• Proprietary Name: Lactulose
• Generic Name: Lactulose
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2001-07-26
• Marketing End Date: 2019-10-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075993
• Labeler Name: Par Pharmaceutical
• Substance Name: LACTULOSE
• Active Ingredient Strength: 10 g/15mL
• Pharm Classes: Osmotic Laxative [EPC],Osmotic Activity [MoA],Acidifying Activity [MoA],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• NDC Exclude Flag: N

Packaging

NDC 0603-1378-65

1892 mL in 1 BOTTLE (0603-1378-65)

• Marketing Start Date: 2001-07-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0603-1378-58 [00603137858]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075993
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-26
• Marketing End Date: 2019-10-31

NDC 0603-1378-45 [00603137845]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075993
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-07-26
• Marketing End Date: 2009-12-10

NDC 0603-1378-56 [00603137856]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075993
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-26
• Marketing End Date: 2019-05-31

NDC 0603-1378-59 [00603137859]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075993
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-26
• Marketing End Date: 2019-08-31

NDC 0603-1378-65 [00603137865]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA075993
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2001-07-26
• Marketing End Date: 2019-08-31

Drug Details

Active Ingredients

Ingredient	Strength
LACTULOSE	10 g/15mL

OpenFDA Data

• SPL SET ID: bd4d1c58-4b9b-47c1-a3c7-64f7a827d408
• Manufacturer:
  • Par Pharmaceutical
• UNII:
  • 9U7D5QH5AE
• RxNorm Concept Unique ID - RxCUI:
  • 391937
• UPC Code:
  • 0306031378652

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