Lactulose (Page 2 of 2)

Manufactured for: Huntsville, AL 35811
QUALITEST PHARMACEUTICALS

8083112 R2/15-R1

LACTULOSE SOLUTION

Label Image
(click image for full-size original)
LACTULOSE
lactulose solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-1378(NDC:0603-1378)
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
FD&C BLUE NO. 1
FD&C YELLOW NO. 6
WATER
SODIUM HYDROXIDE
Product Characteristics
Color GREEN (clear) Score
Shape Size
Flavor BANANA Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-1378-1 30 mL in 1 CUP None
2 NDC:17856-1378-2 15 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075993 07/26/2001
Labeler — Atlantic Biologicals Corps (047437707)
Registrant — Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Operations
Atlantic Biologicals Corps 047437707 RELABEL (17856-1378), REPACK (17856-1378)

Revised: 10/2019 Atlantic Biologicals Corps

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