NDC Code(s) : 80830-1693-1, 80830-1693-5, 80830-1693-3, 80830-1691-1, 80830-1691-5, 80830-1691-2, 80830-1692-1, 80830-1692-5, 80830-1692-2
Packager : Puniska Healthcare Private Limited

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

POTASSIUM PHOSPHATESpotassium phosphate, monobasic potassium phosphate, dibasic injection, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80830-1693
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
(PHOSPHATE ION - UNII:NK08V8K8HR) 		POTASSIUM PHOSPHATE, MONOBASIC224 mg in 1 mL
POTASSIUM PHOSPHATE, DIBASIC(UNII: CI71S98N1Z)
(PHOSPHATE ION - UNII:NK08V8K8HR) 		POTASSIUM PHOSPHATE, DIBASIC236 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80830-1693-525 in 1 CARTON 23/10/2023
1NDC:80830-1693-15 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:80830-1693-35 in 1 CARTON 23/10/2023
2NDC:80830-1693-15 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216344 10/23/2023
POTASSIUM PHOSPHATESpotassium phosphate, monobasic potassium phosphate, dibasic injection, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80830-1691
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
(PHOSPHATE ION - UNII:NK08V8K8HR) 		POTASSIUM PHOSPHATE, MONOBASIC224 mg in 1 mL
POTASSIUM PHOSPHATE, DIBASIC(UNII: CI71S98N1Z)
(PHOSPHATE ION - UNII:NK08V8K8HR) 		POTASSIUM PHOSPHATE, DIBASIC236 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80830-1691-525 in 1 CARTON 23/10/2023
1NDC:80830-1691-115 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
2NDC:80830-1691-210 in 1 CARTON 23/10/2023
2NDC:80830-1691-115 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216344 10/23/2023
POTASSIUM PHOSPHATESpotassium phosphate, monobasic potassium phosphate, dibasic injection, SOLUTION, CONCENTRATE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:80830-1692
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POTASSIUM PHOSPHATE, MONOBASIC(UNII: 4J9FJ0HL51)
(PHOSPHATE ION - UNII:NK08V8K8HR) 		POTASSIUM PHOSPHATE, MONOBASIC224 mg in 1 mL
POTASSIUM PHOSPHATE, DIBASIC(UNII: CI71S98N1Z)
(PHOSPHATE ION - UNII:NK08V8K8HR) 		POTASSIUM PHOSPHATE, DIBASIC236 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:80830-1692-525 in 1 CARTON 23/10/2023
1NDC:80830-1692-150 mL in 1 VIAL Type 0: Not a Combination Product
2NDC:80830-1692-210 in 1 CARTON 23/10/2023
2NDC:80830-1692-150 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 ANDA216344 10/23/2023

LABELER - Puniska Healthcare Private Limited(675474666)

Establishment
Name Address ID/FEI Business Operations
Puniska Healthcare Private Limited 675474666 analysis(80830-1693, 80830-1691, 80830-1692), label(80830-1693, 80830-1691, 80830-1692), manufacture(80830-1693, 80830-1691, 80830-1692), pack(80830-1693, 80830-1691, 80830-1692), sterilize(80830-1693, 80830-1691, 80830-1692)

PRINCIPAL DISPLAY PANEL

NDC 80830-1693-1

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 15 mmol/5 mL (3 mmol/mL)

Potassium 22 mEq/5 mL (4.4 mEq/mL) 

5 mL Vial Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1693-5

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 15 mmol/5 mL (3 mmol/mL)

Potassium 22 mEq/5 mL (4.4 mEq/mL) 

25 x 5 mL Carton Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1693-3

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 15 mmol/5 mL (3 mmol/mL)

Potassium 22 mEq/5 mL (4.4 mEq/mL) 

5 x 5 mL Carton Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1691-1

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 45 mmol/15 mL (3 mmol/mL)

Potassium 66 mEq/15 mL (4.4 mEq/mL) 

15 mL Vial Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1691-5

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 45 mmol/15 mL (3 mmol/mL)

Potassium 66 mEq/15 mL (4.4 mEq/mL) 

25 x 1 5 mL Carton Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1691-2

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 45 mmol/15 mL (3 mmol/mL)

Potassium 66 mEq/15 mL (4.4 mEq/mL) 

10 x 15 mL Carton Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1692-1

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 150 mmol/50 mL (3 mmol/mL)

Potassium 220 mEq/50 mL (4.4 mEq/mL) 

50 mL Pharmacy Bulk Package Vial Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1692-5

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 150 mmol/50 mL (3 mmol/mL)

Potassium 220 mEq/50 mL (4.4 mEq/mL) 

25 x 50 mL Pharmacy Bulk Package Carton Label

Rx only

Amneal Pharmaceuticals LLC

1

NDC 80830-1692-2

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 150 mmol/50 mL (3 mmol/mL)

Potassium 220 mEq/50 mL (4.4 mEq/mL) 

10 x 50 mL Pharmacy Bulk Package Carton Label

Rx only

Amneal Pharmaceuticals LLC

1

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 150 mmol/50 mL (3 mmol/mL)

Potassium 220 mEq/50 mL (4.4 mEq/mL) 

25 x 50 mL Sticker Label (Pharmacy Bulk Package)

Amneal Pharmaceuticals LLC

1

POTASSIUM PHOSPHATES INJECTION, USP

Phosphorus 150 mmol/50 mL (3 mmol/mL)

Potassium 220 mEq/50 mL (4.4 mEq/mL) 

10 x 50 mL  Sticker Label (Pharmacy Bulk Package)

Amneal Pharmaceuticals LLC

1