Sucraid (Page 4 of 4)

118 mL Multi-dose bottle

Carton:

Carton Label 1
(click image for full-size original)

Bottle label:

bottle
(click image for full-size original)

2 mL Single-use container

Carton:

carton2
(click image for full-size original)

Box:

carton3
(click image for full-size original)

Pouch:

pouch
(click image for full-size original)

Single-use container:

vials
(click image for full-size original)
SUCRAID sacrosidase solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:67871-111
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
sacrosidase (sacrosidase) sacrosidase 8500 [iU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
glycerin
WATER
ANHYDROUS CITRIC ACID
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67871-111-04 2 BOTTLE in 1 CARTON contains a BOTTLE (67871-111-01)
1 NDC:67871-111-01 118 mL in 1 BOTTLE This package is contained within the CARTON (67871-111-04)
2 NDC:67871-111-07 6 BOX in 1 CARTON contains a BOX (67871-111-06)
2 NDC:67871-111-06 25 POUCH in 1 BOX This package is contained within the CARTON (67871-111-07) and contains a POUCH (67871-111-05)
2 NDC:67871-111-05 5 VIAL, SINGLE-USE in 1 POUCH This package is contained within the BOX (67871-111-06) and contains a VIAL, SINGLE-USE
2 2 mL in 1 VIAL, SINGLE-USE This package is contained within a POUCH (67871-111-05) and a BOX (67871-111-06) and a CARTON (67871-111-07)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA020772 04/09/1998
Labeler — QOL Medical, LLC (140026258)
Establishment
Name Address ID/FEI Operations
QOL MEDICAL 104085889 api manufacture (67871-111), analysis (67871-111)
Establishment
Name Address ID/FEI Operations
Lyophilization Services of New England, Inc. (LSNE) 028180765 manufacture (67871-111)
Establishment
Name Address ID/FEI Operations
Woodstock Sterile Solutions, Inc. 117895702 manufacture (67871-111)

Revised: 05/2022 QOL Medical, LLC

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