Home NDC 0517-2505 Potassium Phosphates
Product NDC 0517-2505
11-digit product format 005172505
Labeler code 0517
Product ID 0517-2505_e76a57d0-94d0-4eed-9969-66f2c553ed5c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Phosphate, Monobasic Potassium Phosphate, Dibasic
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 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 · 66 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 2026-09-14 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…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216274-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216274-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216274-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-02 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 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 2026-12-31 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 CI71S98N1Z Internal UNII lookup 4J9FJ0HL51 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 0517-2505-01 Potassium Phosphates 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION 50 10 0517-2505-25 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 0517-2505 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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0517-2505-01 00517250501 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 50 ml Historical 0517-2505-25 00517250525 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01) 2023-10-13 No No Current