Home NDC 17478-920 BALANCED SALT
Product NDC 17478-920
11-digit product format 174780920
Labeler code 17478
Product ID 17478-920_43bab898-d618-4354-b90d-e5a4c0d594a8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Calcium Chloride, Magnesium Chloride, Potassium Chloride, Sodium Acetate, Sodium Chloride, Sodium Citrate
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Akorn
Application ANDA075503
Marketing category ANDA
Marketing start 2006-09-27
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 · 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 17478-920-19 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 (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 Magnesium Chloride ACTIVE INGREDIENT 02F3473H9O BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 Potassium Chloride ACTIVE INGREDIENT 660YQ98I10 BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 Sodium Acetate ACTIVE INGREDIENT 4550K0SC9B BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 Sodium Chloride ACTIVE INGREDIENT 451W47IQ8X BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 Sodium Citrate ACTIVE INGREDIENT 1Q73Q2JULR BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 calcium cation ACTIVE MOIETY 2M83C4R6ZB BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 magnesium cation ACTIVE MOIETY T6V3LHY838 BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 POTASSIUM CATION ACTIVE MOIETY 295O53K152 BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5 SODIUM CATION ACTIVE MOIETY LYR4M0NH37 BALANCED SALT (CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, POTASSIUM CHLORIDE, SODIUM ACETATE, SODIUM CHLORIDE, SODIUM CITRATE) SOLUTION [AKORN, INC.] 5
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17478-920-19 17478092019 1 BOTTLE, PLASTIC in 1 POUCH (17478-920-19) > 18 mL in 1 BOTTLE, PLASTIC 2006-09-27 0000-00-00 No No Current