Home NDC 70121-1722 POTASSIUM PHOSPHATES
Product NDC 70121-1722
11-digit product format 701211722
Labeler code 70121
Product ID 70121-1722_def7f258-3637-4362-b77d-e16904796cd5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Potassium Phosphates in sodium chloride
Dosage form INJECTION
Route INTRAVENOUS
Labeler Amneal Pharmaceuticals LLC
Application NDA218343
Marketing category NDA
Marketing start 2024-07-30
Substance POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Active strength 4.72; 4.48 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 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N218343-001 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 2024-07-26
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.
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 2026-02-19 14:30 UTC 2026-02 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 79d66fd596c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N218343-001 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE 1.18GM/250ML (4.72MG/ML);1.12GM/250ML (4.48MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2024-07-26 a50c72e98297…
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 4.72 mg/mL POTASSIUM PHOSPHATE, DIBASIC 4.48 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2688947 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 70121-1722-9 POTASSIUM PHOSPHATES 1 in 1 POUCH INJECTION 1 5 70121-1722-9 POTASSIUM PHOSPHATES 24 in 1 CARTON INJECTION 24 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70121-1722 POTASSIUM PHOSPHATES (POTASSIUM PHOSPHATES IN SODIUM CHLORIDE) INJECTION [AMNEAL PHARMACEUTICALS LLC] 2 Current NDC, 2 package rows 20240731_dce22c93-aa48-48a9-ac8b-716400d33c9e.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 70121-1722-9 70121172209 24 POUCH in 1 CARTON (70121-1722-9) / 1 BAG in 1 POUCH / 250 mL in 1 BAG 24 pouch 2024-07-30 No No Current