NDC 45963-438

Enulose

Lactulose

Enulose is a Oral; Rectal Solution in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Lactulose.

• Product ID: 45963-438_bda4ccaa-fa33-4911-b3bd-12391c365f47
• NDC: 45963-438
• Product Type: Human Prescription Drug
• Proprietary Name: Enulose
• Generic Name: Lactulose
• Dosage Form: Solution
• Route of Administration: ORAL; RECTAL
• Marketing Start Date: 2011-02-28
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090502
• Labeler Name: Actavis Pharma, Inc.
• 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 45963-438-64

473 mL in 1 BOTTLE (45963-438-64)

• Marketing Start Date: 2011-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 45963-438-64 [45963043864]

Enulose SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA090502
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2011-02-28

Drug Details

Active Ingredients

Ingredient	Strength
LACTULOSE	10 g/15mL

OpenFDA Data

• SPL SET ID: 00c42c5c-d19e-4130-aa08-a8bbd47d3e5b
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • 9U7D5QH5AE
• RxNorm Concept Unique ID - RxCUI:
  • 755470
  • 391937

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]

Medicade Reported Pricing

45963043864 ENULOSE 10 GM/15 ML SOLUTION

Pricing Unit: ML | Drug Type:

NDC Crossover Matching brand name "Enulose" or generic name "Lactulose"

NDC	Brand Name	Generic Name
45963-438	Enulose	Enulose
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