Lactulose (Page 2 of 2)

Package/Label Display Panel

Delivers 30 mL

NDC 50383-357-30

LACTULOSE SOLUTION, USP 20g/30 mL

Indications: For the treatment

of constipation. See Insert.

Rx ONLY

Package/Label Display Panel

Delivers 15 mL

NDC 50383-356-15

LACTULOSE SOLUTION, USP 10g/15 mL

Indications: For the treatment

of constipation. See Insert.

Rx ONLY

LACTULOSE lactulose solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-779 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTULOSE (LACTULOSE) LACTULOSE 10 g in 15 mL

Inactive Ingredients Ingredient Name Strength GALACTOSE WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-779-17 4 TRAY in 1 CASE contains a TRAY (50383-779-15) 1 NDC:50383-779-15 10 CUP in 1 TRAY This package is contained within the CASE (50383-779-17) and contains a CUP 1 15 mL in 1 CUP This package is contained within a TRAY (50383-779-15) and a CASE (50383-779-17) 2 NDC:50383-779-31 4 TRAY in 1 CASE contains a TRAY (50383-779-30) 2 NDC:50383-779-30 10 CUP in 1 TRAY This package is contained within the CASE (50383-779-31) and contains a CUP 2 30 mL in 1 CUP This package is contained within a TRAY (50383-779-30) and a CASE (50383-779-31) 3 NDC:50383-779-33 10 TRAY in 1 CASE contains a TRAY 3 10 CUP in 1 TRAY This package is contained within the CASE (50383-779-33) and contains a CUP 3 30 mL in 1 CUP This package is contained within a TRAY and a CASE (50383-779-33) 4 NDC:50383-779-08 237 mL in 1 BOTTLE None 5 NDC:50383-779-16 473 mL in 1 BOTTLE None 6 NDC:50383-779-32 946 mL in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074076 07/03/1995

LACTULOSE lactulose solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-357 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTULOSE (LACTULOSE) LACTULOSE 10 g in 15 mL

Inactive Ingredients Ingredient Name Strength GALACTOSE WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-357-33 10 TRAY in 1 CASE contains a TRAY 1 10 CUP in 1 TRAY This package is contained within the CASE (50383-357-33) and contains a CUP (50383-357-30) 1 NDC:50383-357-30 30 mL in 1 CUP This package is contained within a TRAY and a CASE (50383-357-33) 2 NDC:50383-357-31 4 TRAY in 1 CASE contains a TRAY 2 10 CUP in 1 TRAY This package is contained within the CASE (50383-357-31) and contains a CUP (50383-357-30) 2 NDC:50383-357-30 30 mL in 1 CUP This package is contained within a TRAY and a CASE (50383-357-31)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074076 07/03/1995

LACTULOSE lactulose solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50383-356 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTULOSE (LACTULOSE) LACTULOSE 10 g in 15 mL

Inactive Ingredients Ingredient Name Strength GALACTOSE WATER SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50383-356-17 4 TRAY in 1 CASE contains a TRAY 1 10 CUP in 1 TRAY This package is contained within the CASE (50383-356-17) and contains a CUP (50383-356-15) 1 NDC:50383-356-15 15 mL in 1 CUP This package is contained within a TRAY and a CASE (50383-356-17)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074076 07/03/1995

Labeler — Akorn (117696873)

Registrant — Akorn Operating Company LLC (117693100)

Establishment
Name	Address	ID/FEI	Operations
Akorn		117696873	MANUFACTURE (50383-779), MANUFACTURE (50383-356), MANUFACTURE (50383-357)

Revised: 01/2023 Akorn