NDC Code(s) : 80830-2362-1, 80830-2362-9, 80830-2363-1, 80830-2363-9
Packager : Puniska Healthcare Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CALCIUM GLUCONATEcalcium gluconate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80830-2362
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE MONOHYDRATE(UNII: CZN0MI5R31)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM GLUCONATE MONOHYDRATE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CALCIUM SACCHARATE(UNII: 6AP9J91K4V)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80830-2362-924 in 1 CARTON 09/08/2023
1NDC:80830-2362-11 in 1 POUCH
150 mL in 1 BAG Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217174 09/08/2023
CALCIUM GLUCONATEcalcium gluconate INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80830-2363
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CALCIUM GLUCONATE MONOHYDRATE(UNII: CZN0MI5R31)
(CALCIUM CATION - UNII:2M83C4R6ZB) 		CALCIUM GLUCONATE MONOHYDRATE20 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CALCIUM SACCHARATE(UNII: 6AP9J91K4V)
HYDROCHLORIC ACID(UNII: QTT17582CB)
SODIUM HYDROXIDE(UNII: 55X04QC32I)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80830-2363-924 in 1 CARTON 09/08/2023
1NDC:80830-2363-11 in 1 POUCH
1100 mL in 1 BAG Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA217174 09/08/2023

LABELER - Puniska Healthcare Private Limited(675474666)

Establishment
Name Address ID/FEI Business Operations
Puniska Healthcare Private Limited 675474666 analysis(80830-2362, 80830-2363), label(80830-2362, 80830-2363), manufacture(80830-2362, 80830-2363), pack(80830-2362, 80830-2363), sterilize(80830-2362, 80830-2363)

PRINCIPAL DISPLAY PANEL

NDC 80830-2362-1

Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (1,000 mg/50 mL)

Rx only

Intravenous Bag Label

Amneal Pharmaceuticals LLC

1

NDC 80830-2362-1

Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (1,000 mg/50 mL)

Rx only

Pouch Label

Amneal Pharmaceuticals LLC

1

NDC 80830-2362-9

Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (1,000 mg/50 mL)

Rx only

24 x 50 mL Carton Label

Amneal Pharmaceuticals LLC

1

NDC 80830-2363-1

Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (2,000 mg/100 mL)

Rx only

Intravenous Bag Label

Amneal Pharmaceuticals LLC

1

NDC 80830-2363-1

Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (2,000 mg/100 mL)

Rx only

Pouch Label

Amneal Pharmaceuticals LLC

1

NDC 80830-2363-9

Calcium Gluconate in Sodium Chloride Injection, 20 mg/mL (2,000 mg/100 mL)

Rx only

24 x 100 mL Carton Label

Amneal Pharmaceuticals LLC

1