Home NDC 80830-1692 POTASSIUM PHOSPHATES
Product NDC 80830-1692
11-digit product format 808301692
Labeler code 80830
Product ID 80830-1692_d20a884f-9cba-4621-91ee-6e0ba6e361ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name potassium phosphate, monobasic potassium phosphate, dibasic injection,
Dosage form SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals Private Limited
Application ANDA216344
Marketing category ANDA
Marketing start 2023-10-23
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 A216344-001 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 A216344-002 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 A216344-003 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10
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 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216344-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216344-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216344-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2023-10-10 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 66 observed states.
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 1928570 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 80830-1692-1 POTASSIUM PHOSPHATES 50 mL in 1 VIAL SOLUTION, CONCENTRATE 50 9 80830-1692-2 POTASSIUM PHOSPHATES 10 in 1 CARTON SOLUTION, CONCENTRATE 10 9 80830-1692-5 POTASSIUM PHOSPHATES 25 in 1 CARTON SOLUTION, CONCENTRATE 25 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80830-1692 POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION,) SOLUTION, CONCENTRATE [AMNEAL PHARMACEUTICALS PRIVATE LIMITED] 9 Current NDC, 3 package rows 20250108_89136c51-a60b-4269-bd05-9489f060a734.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 · 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 INJECTION, Amneal Pharmaceuticals Private Limited 98315c6e-308d-423b-a046-4be1f54d30ae 2026-09-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216344 application number: ANDA216344 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, Amneal Pharmaceuticals Private Limited 125121b8-bc4c-44ee-906e-e72f652a5aa6 2026-09-01 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216344 application number: ANDA216344 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, MONOBASIC POTASSIUM PHOSPHATE, DIBASIC INJECTION, Amneal Pharmaceuticals Private Limited 89136c51-a60b-4269-bd05-9489f060a734 2024-12-31 Warnings, Adverse reactions Exact identifier application applno (ANDA): 216344 application number: ANDA216344 ndc (product): 80830-1692
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80830-1692-1 80830169201 50 mL in 1 VIAL 50 ml Historical 80830-1692-2 80830169202 10 VIAL in 1 CARTON (80830-1692-2) / 50 mL in 1 VIAL (80830-1692-1) 10 vial 2023-10-23 No No Current 80830-1692-5 80830169205 25 VIAL in 1 CARTON (80830-1692-5) / 50 mL in 1 VIAL (80830-1692-1) 25 vial 2023-10-23 No No Current