Home NDC 0517-2051 Potassium Phosphates
Product NDC 0517-2051
11-digit product format 005172051
Labeler code 0517
Product ID 0517-2051_fb3f7fdb-b5ba-4295-a020-39cfa0c8d931
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name potassium phosphates
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA216274
Marketing category ANDA
Marketing start 2023-10-13
Substance POTASSIUM PHOSPHATE, MONOBASIC; POTASSIUM PHOSPHATE, DIBASIC
Active strength 224; 236 mg/mL; mg/mL
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Compounds [CS], Potassium Salt [EPC], Potassium Salt [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216274-001 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 A216274-002 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 A216274-003 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 69 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-10-15 13:18:30 2026-09 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 79d66fd596c7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 69 observed states.
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Potassium Phosphates
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM PHOSPHATE, MONOBASIC 224 mg/mL POTASSIUM PHOSPHATE, DIBASIC 236 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4J9FJ0HL51 Internal UNII lookup CI71S98N1Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1928567 Internal RxNorm lookup 1928569 Internal RxNorm lookup 2667657 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0517-2051-01 Potassium Phosphates 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 5 10 0517-2051-25 Potassium Phosphates 25 in 1 TRAY INJECTION, SOLUTION 25 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-2051 POTASSIUM PHOSPHATES INJECTION, SOLUTION POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC) INJECTION, SOLUTION POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE) INJECTION, SOLUTION [AMERICAN REGENT, INC.] 10 Current NDC, 2 package rows 20250210_41a85cca-c463-4f39-9335-177b04c290a9.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0517-2051-01 00517205101 5 mL in 1 VIAL, SINGLE-DOSE 5 ml Historical 0517-2051-25 00517205125 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) 2023-10-13 No No Current