Lactulose (Page 2 of 2)

Package/Label Display Panel

Unit dose lid -- 30 mL

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

Unit dose Lid 15 mL

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

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