NDC 13668-574

Lactulose

Lactulose

Lactulose is a Oral; Rectal Solution in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Lactulose.

• Product ID: 13668-574_9550779e-52e7-4183-8112-c01efa4843b9
• NDC: 13668-574
• Product Type: Human Prescription Drug
• Proprietary Name: Lactulose
• Generic Name: Lactulose
• Dosage Form: Solution
• Route of Administration: ORAL; RECTAL
• Marketing Start Date: 2018-06-14
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203762
• Labeler Name: Torrent Pharmaceuticals Limited
• Substance Name: LACTULOSE
• Active Ingredient Strength: 10 g/15mL
• Pharm Classes: Acidifying Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 13668-574-08

237 mL in 1 BOTTLE (13668-574-08)

• Marketing Start Date: 2018-06-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 13668-574-08 [13668057408]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203762
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-14

NDC 13668-574-12 [13668057412]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203762
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-14

NDC 13668-574-10 [13668057410]

Lactulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203762
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-06-14

Drug Details

Active Ingredients

Ingredient	Strength
LACTULOSE	10 g/15mL

OpenFDA Data

• SPL SET ID: a04fb99f-b65c-4e43-9bd4-1fd6f62477f5
• Manufacturer:
  • Torrent Pharmaceuticals Limited
• UNII:
  • 9U7D5QH5AE
• RxNorm Concept Unique ID - RxCUI:
  • 391937
• UPC Code:
  • 0313668574128

Pharmacological Class

• Osmotic Laxative [EPC]
• Osmotic Activity [MoA]
• Acidifying Activity [MoA]
• Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Medicade Reported Pricing

13668057410 LACTULOSE 10 GM/15 ML SOLUTION

Pricing Unit: ML | Drug Type:

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