Home NDC 0264-2514 Balanced Salt
Product NDC 0264-2514
11-digit product format 002642514
Labeler code 0264
Product ID 0264-2514_445be296-044a-4175-b52b-b98335ca5855
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 2010-02-03
Marketing end 0000-00-00
Substance CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM CITRATE
Active strength 0 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], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0264-2514-10 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 0264-2514-10 f5e01cc5f278…a2eaf40c39c3…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 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 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 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 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 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 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 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 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 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 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 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 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 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 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 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 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 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 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 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 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 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 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 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 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 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 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 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 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 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 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 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 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 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 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 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 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 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 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 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 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 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 87673890dc5c…2021-03-12 10:30 UTC 2021-03 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 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 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 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 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 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 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 3f01610625f2…2019-09-15 20:21 UTC 2019-09 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 b00525d2431f…2019-07-19 19:46 UTC 2019-07 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 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 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 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 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 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 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 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 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 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 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 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 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 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 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 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 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 053a50430f4f…2023-01-26 05:58 UTC 2023-01 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 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 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 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 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 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Calcium Chloride ACTIVE INGREDIENT M4I0D6VV5M BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Magnesium Chloride ACTIVE INGREDIENT 02F3473H9O BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Potassium Chloride ACTIVE INGREDIENT 660YQ98I10 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Sodium Acetate ACTIVE INGREDIENT 4550K0SC9B BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Sodium Chloride ACTIVE INGREDIENT 451W47IQ8X BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Sodium Citrate ACTIVE INGREDIENT 1Q73Q2JULR BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 CALCIUM CATION ACTIVE MOIETY 2M83C4R6ZB BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 MAGNESIUM CATION ACTIVE MOIETY T6V3LHY838 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 POTASSIUM CATION ACTIVE MOIETY 295O53K152 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Hydrochloric Acid INACTIVE INGREDIENT QTT17582CB BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3 Water INACTIVE INGREDIENT 059QF0KO0R BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0264-2514 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE) SOLUTION [B. BRAUN MEDICAL INC.] 13 Legacy NDC 20220223_f47d4c31-8871-74dd-2e13-52af971a69e0.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Balanced Salt SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE, AND SODIUM CITRATE B. Braun Medical Inc. 74ab8883-0a5f-46b4-8998-9358f6fd4ef4 2024-03-13 Warnings, Adverse reactions Exact identifier application applno (ANDA): 091387 application number: ANDA091387
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0264-2514-10 00264251410 12 BOTTLE, GLASS in 1 CASE (0264-2514-10) > 500 mL in 1 BOTTLE, GLASS 2010-02-03 0000-00-00 No No Current