Home NDC 65219-656 Potassium Phosphates
Product NDC 65219-656
11-digit product format 652190656
Labeler code 65219
Product ID 65219-656_b813e96f-27c8-4bb1-ba28-6319ee823a14
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Phosphates
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA212832
Marketing category NDA
Marketing start 2025-06-15
Substance MONOBASIC POTASSIUM PHOSPHATE; DIBASIC POTASSIUM PHOSPHATE
Active strength 11.2; 11.8 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 44 .
Orange Book products# Current product rows page 1 of 1 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N212832-001 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 N212832-002 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 N212832-003 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 4 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22
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 4 · 137 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 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 c2088c7a36db…2026-09-14 22:38:34 2026-08 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/100ML (11.8MG/ML);1.12GM/100ML (11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML(236MG/ML); 1.12GM/5ML(224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML(236MG/ML); 3.36GM/15ML(224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML(236MG/ML); 11.2GM/50ML(224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-004 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/100ML(11.8MG/ML); 1.12GM/100ML(11.2MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-005 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML(4.72MG/ML); 1.12GM/250ML(4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2025-05-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212832-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212832-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212832-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2019-11-26 2680178bc6a6…
Observed Orange Book normalized TE history# Normalized TE history page 2 of 2 · 69 observed states.
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 c2088c7a36db…2026-10-15 13:18:30 2026-09 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 c2088c7a36db…2026-09-14 22:38:34 2026-08 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212832-004 11813291 2041-10-12 U-4185 Drug product 2025-05-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212832-004 11925661 2041-10-12 U-4185 Drug product 2025-05-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212832-005 11813291 2041-10-12 U-4185 Drug product 2025-05-22 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212832-005 11925661 2041-10-12 U-4185 Drug product 2025-05-22 a50c72e98297…
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 MONOBASIC POTASSIUM PHOSPHATE 11.2 mg/mL DIBASIC POTASSIUM PHOSPHATE 11.8 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2688947 Internal RxNorm lookup 2716829 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 65219-656-01 Potassium Phosphates 100 mL in 1 BAG INJECTION, SOLUTION 100 2 65219-656-01 Potassium Phosphates 1 in 1 POUCH INJECTION, SOLUTION 1 2 65219-656-10 Potassium Phosphates 24 in 1 CARTON INJECTION, SOLUTION 24 2
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 · 3 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC CIVICA, INC. f7702b2f-d0d1-4696-896d-571607fc0dc8 2026-07-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 212832 application number: NDA212832 Potassium Phosphates POTASSIUM PHOSPHATES Fresenius Kabi USA, LLC 357c3020-ea6f-4401-a2e7-cebb82b03144 2025-04-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 212832 application number: NDA212832 ndc (product): 65219-656 Potassium Phosphates POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC Fresenius Kabi USA, LLC 475f5cd7-45bd-412a-b419-9962585d6cda 2025-02-28 Warnings, Adverse reactions Exact identifier application applno (NDA): 212832 application number: NDA212832
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65219-656-01 65219065601 100 mL in 1 BAG 100 ml Historical 65219-656-10 65219065610 24 POUCH in 1 CARTON (65219-656-10) / 1 BAG in 1 POUCH (65219-656-01) / 100 mL in 1 BAG 24 pouch 2025-06-15 No No Current