NDC 66220-719

Kristalose

Lactulose

Kristalose is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cumberland Pharmaceuticals Inc.. The primary component is Lactulose.

• Product ID: 66220-719_22d5911b-d3d5-464d-a7ae-a01fc51defb1
• NDC: 66220-719
• Product Type: Human Prescription Drug
• Proprietary Name: Kristalose
• Generic Name: Lactulose
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2012-01-20
• Marketing Category: ANDA / ANDA
• Application Number: ANDA074712
• Labeler Name: Cumberland Pharmaceuticals Inc.
• Substance Name: LACTULOSE
• Active Ingredient Strength: 10 g/10g
• 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: 2020-12-31

Packaging

NDC 66220-719-30

30 POUCH in 1 CARTON (66220-719-30) > 10 g in 1 POUCH (66220-719-01)

• Marketing Start Date: 2012-01-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66220-719-01 [66220071901]

Kristalose POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074712
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-20

NDC 66220-719-30 [66220071930]

Kristalose POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA074712
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-01-20

Drug Details

Active Ingredients

Ingredient	Strength
LACTULOSE	10 g/10g

OpenFDA Data

• SPL SET ID: 535dd1ea-b567-49f7-9a84-8ea91e78c466
• Manufacturer:
  • Cumberland Pharmaceuticals Inc.
• UNII:
  • 9U7D5QH5AE
• RxNorm Concept Unique ID - RxCUI:
  • 1251194
  • 1251196
  • 1251190
  • 1251192
• UPC Code:
  • 0366220729016
  • 0366220719017

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

66220071930 KRISTALOSE 10 GM PACKET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
66220-719	Kristalose	Kristalose
66220-729	Kristalose	Kristalose
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