Home NDC 65145-196 POTASSIUM PHOSPHATES
Product NDC 65145-196
11-digit product format 651450196
Labeler code 65145
Product ID 65145-196_fbbd8380-9848-4862-8c73-2f53fcdf7120
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name POTASSIUM PHOSPHATES
Dosage form INJECTION, SOLUTION, CONCENTRATE
Route INTRAVENOUS
Labeler Caplin Steriles Limited
Application ANDA220373
Marketing category ANDA
Marketing start 2026-03-16
Substance POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC
Active strength 236; 224 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 1 .
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 A220373-001 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 A220373-002 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 A220373-003 POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC; POTASSIUM PHOSPHATE, MONOBASIC 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12
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.
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220373-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220373-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220373-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220373-001 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220373-002 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220373-003 AP 1 a50c72e98297…
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 236 mg/mL POTASSIUM PHOSPHATE, DIBASIC 224 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 65145-196-01 POTASSIUM PHOSPHATES 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, SOLUTION, CONCENTRATE 50 1 65145-196-25 POTASSIUM PHOSPHATES 25 in 1 CARTON INJECTION, SOLUTION, CONCENTRATE 25 1
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 · 2 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 65145-196-01 65145019601 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 50 ml Historical 65145-196-25 65145019625 25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (65145-196-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (65145-196-01) 2026-03-16 No No Current