Home NDC 0517-7350 Sodium Phosphates
Product NDC 0517-7350
11-digit product format 005177350
Labeler code 0517
Product ID 0517-7350_4b71a79f-83da-45b0-a398-4833ecc17ba4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic anhydrous
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler American Regent, Inc.
Application ANDA218314
Marketing category ANDA
Marketing start 2024-06-21
Substance SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength 142; 276 mg/mL; mg/mL
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A218314-001 SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 A218314-002 SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 A218314-003 SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21
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 2026-02-19 14:30 UTC 2026-02 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A218314-001 SODIUM PHOSPHATES 142MG/ML;276MG/ML INJECTABLE / INJECTION AP 2024-06-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A218314-001 SODIUM PHOSPHATES 142MG/ML;276MG/ML INJECTABLE / INJECTION AP 2024-06-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A218314-001 SODIUM PHOSPHATES 142MG/ML;276MG/ML INJECTABLE / INJECTION AP 2024-06-21 301d65b070ca…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218314-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218314-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A218314-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML;276MG/ML) SOLUTION / INTRAVENOUS AP 2024-06-21 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Sodium Phosphates
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 142 mg/mL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 276 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 593YOG76RN Internal UNII lookup 22ADO53M6F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1872384 Internal RxNorm lookup 1872443 Internal RxNorm lookup 1872447 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 0517-7350-01 Sodium Phosphates 50 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 50 2 0517-7350-25 Sodium Phosphates 25 in 1 TRAY INJECTION, SOLUTION 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0517-7350 SODIUM PHOSPHATES (SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUS) INJECTION, SOLUTION [AMERICAN REGENT, INC.] 2 Current NDC, 2 package rows 20240625_dc0462ee-4486-418c-865f-e2a71bdb8e9e.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUS Civica, Inc. 8fd901e6-30cb-411a-b820-b9e79625ec7c 2025-08-08 Warnings, Adverse reactions Exact identifier application applno (ANDA): 218314 application number: ANDA218314 Sodium Phosphates SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC ANHYDROUS American Regent, Inc. dc0462ee-4486-418c-865f-e2a71bdb8e9e 2024-06-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 218314 application number: ANDA218314 ndc (product): 0517-7350
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1872443 sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) in 5 ML Injection PSN dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872447 sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) in 50 ML Injection PSN dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872384 sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) in 15 ML Injection PSN dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872384 15 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML Injection SCD dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872443 5 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML Injection SCD dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872447 50 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML Injection SCD dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872384 phosphorus 45 MMOL / sodium 60 MEQ per 15 ML Injection SY dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872384 sodium phosphate, dibasic 2.13 GM / sodium phosphate, monobasic 4.14 GM per 15 ML Injection SY dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872443 sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) per 5 ML Injection SY dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872447 sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) per 50 ML Injection SY dc0462ee-4486-418c-865f-e2a71bdb8e9e 2 1872384 sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) per 15 ML Injection SY dc0462ee-4486-418c-865f-e2a71bdb8e9e 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0517-7350-01 00517735001 50 mL in 1 VIAL, SINGLE-DOSE 50 ml Historical 0517-7350-25 00517735025 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-7350-25) / 50 mL in 1 VIAL, SINGLE-DOSE (0517-7350-01) 2024-06-21 No No Current