NDC Code(s) : 68083-498-25, 68083-499-25, 68083-608-25
Packager : Gland Pharma Limited

Category : Human Prescription Drug Label

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-498
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC SULFATE(UNII: 89DS0H96TB)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SULFURIC ACID(UNII: O40UQP6WCF)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-498-2525 in 1 CARTON 05/03/2022
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216249 05/03/2022
Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-499
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC SULFATE(UNII: 89DS0H96TB)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SULFURIC ACID(UNII: O40UQP6WCF)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-499-2525 in 1 CARTON 05/03/2022
15 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216249 05/03/2022
Zinc Sulfate Zinc Sulfate INJECTION, SOLUTION
Product Information
Product Type Human Prescription Drug Label Item Code (Source) NDC:68083-608
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC SULFATE(UNII: 89DS0H96TB)
(ZINC CATION - UNII:13S1S8SF37) 		ZINC CATION1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SULFURIC ACID(UNII: O40UQP6WCF)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68083-608-2525 in 1 CARTON 09/01/2023
110 mL in 1 VIAL Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216249 09/01/2023

LABELER - Gland Pharma Limited(918601238)

Establishment
Name Address ID/FEI Business Operations
Gland Pharma Limited 858971074 ANALYSIS(68083-498, 68083-499, 68083-608), MANUFACTURE(68083-498, 68083-499, 68083-608), PACK(68083-498, 68083-499, 68083-608)

PRINCIPAL DISPLAY PANEL

Carton Label (30 mg/10 mL):

NDC 68083-498-25             Rx only

Zinc Sulfate Injection, USP

30 mg*/10 mL
(3 mg*/mL) of Zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE - Not for Direct Infusion

STERILE                                 25x10 mL VIALS

zincsulfate-spl-carton-label-3mg-per-ml

 

Vial Label (30 mg/10 mL) :

NDC 68083-498-01            Rx only

Zinc Sulfate

Injection, USP

30 mg*/10 mL
(3 mg*/mL) of Zinc

For intravenous use after
dilution and admixing

PHARMACY BULK PACKAGE
- Not for Direct Infusion

STERILE                10 mL

zincsulfate-spl-carton-label-3mg-per-ml

Carton Label (25 mg/5 mL):

NDC 68083-499-25            Rx only

Zinc Sulfate Injection, USP

25 mg*/5 mL
(5 mg*/mL) of Zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE - Not for Direct Infusion

STERILE                         25x5 mL VIALS

zincsulfate-spl-carton-label-3mg-per-ml

Vial Label (25 mg/5 mL):

NDC 68083-499-01         Rx only

Zinc Sulfate

Injection, USP

25 mg*/5 mL
(5 mg*/mL) of Zinc

For intravenous use after
dilution and admixing

PHARMACY BULK PACKAGE
- Not for Direct Infusion

STERILE                   5 mL

zincsulfate-spl-carton-label-3mg-per-ml

  

Carton Label (10 mg/10 mL):

NDC 68083-608-25             Rx only

Zinc Sulfate Injection, USP

10 mg*/10 mL
(1 mg*/mL) of Zinc

For intravenous use after dilution and admixing

PHARMACY BULK PACKAGE - Not for Direct Infusion

STERILE                                 25x10 mL VIALS

 

zincsulfate-spl-carton-label-3mg-per-ml 

Vial Label  (10 mg/10 mL) :

NDC 68083-608-01            Rx only

Zinc Sulfate

Injection, USP

10 mg*/10 mL
(1 mg*/mL) of Zinc

For intravenous use after
dilution and admixing

PHARMACY BULK PACKAGE
- Not for Direct Infusion

STERILE                10 mL

zincsulfate-spl-carton-label-3mg-per-ml