Home NDC 0264-1945-10 Balanced Salt
Product NDC 0264-1945
Requested package NDC 0264-1945-10
11-digit product format 002641945
Labeler code 0264
Product ID 0264-1945_e2d4babc-3f0e-454c-ba77-e2f82fddff51
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate, and Sodium Citrate
Dosage form SOLUTION
Route IRRIGATION
Labeler B. Braun Medical Inc.
Application ANDA091387
Marketing category ANDA
Marketing start 2022-01-28
Substance CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
Active strength .48; .3; .75; 3.9; 6.4; 1.7 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
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 A091387-001 BALANCED SALT CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091387-001 AT
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 2026-08-01 22:54:32 2026-06 A091387-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2010-02-03 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A091387-001 AT 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base Balanced Salt
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM CHLORIDE .48 mg/mL POTASSIUM CHLORIDE .3 mg/mL CALCIUM CHLORIDE .75 mg/mL MAGNESIUM CHLORIDE 3.9 mg/mL SODIUM ACETATE 6.4 mg/mL SODIUM CITRATE 1.7 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 6 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 806392 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 0264-1945-10 Balanced Salt 500 mL in 1 BAG SOLUTION 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-1945 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 2 Current NDC, Legacy NDC, 1 package rows 20240316_74ab8883-0a5f-46b4-8998-9358f6fd4ef4.zip
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 806392 calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % Ophthalmic Solution PSN 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2 806392 calcium chloride 0.004 MEQ/ML / magnesium chloride 0.003 MEQ/ML / potassium chloride 0.01 MEQ/ML / sodium acetate 0.0475 MEQ/ML / sodium chloride 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution SCD 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2 806392 Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / K+ Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution SY 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2 806392 Calcium Chloride 0.004 MEQ/ML / Magnesium Chloride 0.003 MEQ/ML / Pot Chloride 0.01 MEQ/ML / Sodium Acetate 0.0475 MEQ/ML / NaCl 0.109 MEQ/ML / sodium citrate 0.012 MEQ/ML Ophthalmic Solution SY 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2 806392 calcium chloride 0.048 % / magnesium chloride 0.03 % / potassium chloride 0.075 % / sodium acetate 0.39 % / sodium chloride 0.64 % / sodium citrate 0.17 % Ophthalmic Solution SY 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0264-1945-10 00264194510 500 mL in 1 BAG (0264-1945-10) 500 ml 2022-01-28 0000-00-00 No No Current