Home NDC 17478-921 Balanced Salt
Product NDC 17478-921
11-digit product format 174780921
Labeler code 17478
Product ID 17478-921_c1ae6cb3-3537-4eb9-902e-6ccb3ab8f1dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sodium Chloride, Potassium Chloride, Calcium Chloride, Magnesium Chloride, Sodium Acetate and Trisodium Citrate Dihydrate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Akorn
Application ANDA075503
Marketing category ANDA
Marketing start 2014-11-27
Marketing end 0000-00-00
Substance CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; TRISODIUM CITRATE DIHYDRATE
Active strength 0 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes Acidifying Activity [MoA], Anti-coagulant [EPC], Blood Coagulation Factor [EPC], Calcium Chelating Activity [MoA], Calcium [CS], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Decreased Coagulation Factor Activity [PE], Increased Coagulation Factor Activity [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 Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], 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 · 24 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 17478-921-95 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 17478-921-95 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17478-921-95 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17478-921-95 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17478-921-95 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17478-921-95 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17478-921-95 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17478-921-95 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17478-921-95 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17478-921-95 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17478-921-95 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17478-921-95 557ba5c1ecfa…9c80585c8c6e…
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 A075503-001 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 2006-09-27
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 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION AT 2006-09-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075503-001 BALANCED SALT 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6.4MG/ML;1.7MG/ML SOLUTION / IRRIGATION 2006-09-27 f41ea6bd6efb…
Observed Orange Book normalized TE history# 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 TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 magnesium chloride ACTIVE INGREDIENT 02F3473H9O BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 potassium chloride ACTIVE INGREDIENT 660YQ98I10 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 sodium acetate ACTIVE INGREDIENT 4550K0SC9B BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 sodium chloride ACTIVE INGREDIENT 451W47IQ8X BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 trisodium citrate dihydrate ACTIVE INGREDIENT B22547B95K BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 anhydrous citric acid ACTIVE MOIETY XF417D3PSL BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 chloride ion ACTIVE MOIETY Q32ZN48698 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 sodium cation ACTIVE MOIETY LYR4M0NH37 BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 hydrochloric acid INACTIVE INGREDIENT QTT17582CB BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R BALANCED SALT (SODIUM CHLORIDE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, SODIUM ACETATE AND TRISODIUM CITRATE DIHYDRATE) SOLUTION [AKORN, INC.] 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17478-921-95 17478092195 1 BOTTLE, GLASS in 1 BOTTLE (17478-921-95) > 500 mL in 1 BOTTLE, GLASS 2014-11-27 0000-00-00 No No Current