Home NDC 65145-194-25 POTASSIUM PHOSPHATES
Product NDC 65145-194
Requested package NDC 65145-194-25
11-digit product format 651450194
Labeler code 65145
Product ID 65145-194_e6c7b072-db35-42c2-9bc2-d25cd20ca8b0
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 2026-09-17
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 2027-12-31
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 · 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 2026-10-15 13:18:30 2026-09 A220373-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220373-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 c2088c7a36db…2026-10-15 13:18:30 2026-09 A220373-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 c2088c7a36db…2026-09-14 22:38:34 2026-08 A220373-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220373-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 A220373-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220373-001 POTASSIUM PHOSPHATES 1.18GM/5ML (236MG/ML);1.12GM/5ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220373-002 POTASSIUM PHOSPHATES 3.54GM/15ML (236MG/ML);3.36GM/15ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A220373-003 POTASSIUM PHOSPHATES 11.8GM/50ML (236MG/ML);11.2GM/50ML (224MG/ML) SOLUTION / INTRAVENOUS AP 2026-03-12 caaa826d4ba7…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# 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POTASSIUM PHOSPHATE, MONOBASIC 224 mg/mL POTASSIUM PHOSPHATE, DIBASIC 236 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65145-194-01 POTASSIUM PHOSPHATES 5 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 5 1 65145-194-25 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 · 1 matching rows.
DailyMed RxNorm Mappings# DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 65145-194-25 65145019425 25 VIAL, SINGLE-DOSE in 1 CARTON (65145-194-25) / 5 mL in 1 VIAL, SINGLE-DOSE (65145-194-01) 2026-09-17 No No Current