Home NDC 68462-729 SODIUM PHOSPHATES
Product NDC 68462-729
11-digit product format 684620729
Labeler code 68462
Product ID 68462-729_c968f70b-a670-4aef-a7e0-89468ad62d9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SODIUM PHOSPHATES
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler GLENMARK PHARMACEUTICALS INC., USA
Application ANDA220683
Marketing category ANDA
Marketing start 2026-02-23
Substance SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength 268; 276 mg/mL; mg/mL
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 A220683-001 SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 1.34GM/5ML;1.38GM/5ML (268MG/ML; 276MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23 A220683-002 SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 4.02GM/15ML;4.14GM/15ML (268MG/ML; 276MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23 A220683-003 SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 13.4GM/50ML;13.8GM/50ML (268MG/ML; 276MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23
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 A220683-001 SODIUM PHOSPHATES 1.34GM/5ML;1.38GM/5ML (268MG/ML; 276MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220683-002 SODIUM PHOSPHATES 4.02GM/15ML;4.14GM/15ML (268MG/ML; 276MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220683-003 SODIUM PHOSPHATES 13.4GM/50ML;13.8GM/50ML (268MG/ML; 276MG/ML) SOLUTION / INTRAVENOUS AP 2026-02-23 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 A220683-001 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220683-002 AP 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A220683-003 AP 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base SODIUM PHOSPHATES
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 268 mg/mL SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 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 70WT22SF4B 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 68462-729-15 SODIUM PHOSPHATES 15 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 15 1 68462-729-25 SODIUM PHOSPHATES 25 in 1 CARTON INJECTION, SOLUTION 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# 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 c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872447 sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) in 50 ML Injection PSN c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872384 sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) in 15 ML Injection PSN c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872384 15 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML Injection SCD c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872443 5 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML Injection SCD c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872447 50 ML sodium phosphate, dibasic 142 MG/ML / sodium phosphate, monobasic 276 MG/ML Injection SCD c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872384 phosphorus 45 MMOL / sodium 60 MEQ per 15 ML Injection SY c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872384 sodium phosphate, dibasic 2.13 GM / sodium phosphate, monobasic 4.14 GM per 15 ML Injection SY c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872443 sodium phosphates (phosphorus 15 MMOL / sodium 20 MEQ) per 5 ML Injection SY c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872447 sodium phosphates (phosphorus 150 MMOL / sodium 200 MEQ) per 50 ML Injection SY c968f70b-a670-4aef-a7e0-89468ad62d9c 1 1872384 sodium phosphates (phosphorus 45 MMOL / sodium 60 MEQ) per 15 ML Injection SY c968f70b-a670-4aef-a7e0-89468ad62d9c 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68462-729-15 68462072915 15 mL in 1 VIAL, SINGLE-DOSE 15 ml Historical 68462-729-25 68462072925 25 VIAL, SINGLE-DOSE in 1 CARTON (68462-729-25) / 15 mL in 1 VIAL, SINGLE-DOSE (68462-729-15) 2026-02-23 No No Current