Home NDC 17478-290 Tobramycin
Product NDC 17478-290
11-digit product format 174780290
Labeler code 17478
Product ID 17478-290_8893a898-9495-4eb6-800a-ede9227c83d8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Akorn
Application ANDA064096
Marketing category ANDA
Marketing start 1996-01-31
Marketing end 0000-00-00
Substance TOBRAMYCIN
Active strength 3 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
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 · 42 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17478-290-20 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 17478-290-10 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17478-290-20 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 17478-290-10 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17478-290-20 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 17478-290-10 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17478-290-20 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 17478-290-10 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17478-290-20 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 17478-290-10 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17478-290-20 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 17478-290-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17478-290-20 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 17478-290-10 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17478-290-20 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 17478-290-10 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17478-290-20 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 17478-290-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17478-290-20 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 17478-290-10 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17478-290-20 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 17478-290-10 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17478-290-20 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 17478-290-10 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 17478-290-10 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 17478-290-10 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 17478-290-10 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…
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 A064096-001 AKTOB TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC 1996-01-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A064096-001 AKTOB 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1996-01-31 cb3db0bc1861…
Observed Orange Book normalized TE history# DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 17478-290-10 Tobramycin 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 7 17478-290-10 Tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 7 17478-290-20 Tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 7 17478-290-20 Tobramycin 2 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Tobramycin ACTIVE INGREDIENT VZ8RRZ51VK TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 Tobramycin ACTIVE INGREDIENT VZ8RRZ51VK TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 TOBRAMYCIN ACTIVE INGREDIENT VZ8RRZ51VK TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 Tobramycin ACTIVE MOIETY VZ8RRZ51VK TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 Tobramycin ACTIVE MOIETY VZ8RRZ51VK TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 TOBRAMYCIN ACTIVE MOIETY VZ8RRZ51VK TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 Benzalkonium Chloride INACTIVE INGREDIENT F5UM2KM3W7 TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 BENZALKONIUM CHLORIDE INACTIVE INGREDIENT F5UM2KM3W7 TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 Boric Acid INACTIVE INGREDIENT R57ZHV85D4 TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 Sodium Chloride INACTIVE INGREDIENT 451W47IQ8X TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 Sodium Hydroxide INACTIVE INGREDIENT 55X04QC32I TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 SODIUM SULFATE INACTIVE INGREDIENT 0YPR65R21J TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 sodium Sulfate INACTIVE INGREDIENT 0YPR65R21J TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 sodium Sulfate INACTIVE INGREDIENT 0YPR65R21J TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 Sulfuric Acid INACTIVE INGREDIENT O40UQP6WCF TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 Sulfuric Acid INACTIVE INGREDIENT O40UQP6WCF TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 Tyloxapol INACTIVE INGREDIENT Y27PUL9H56 TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 Tyloxapol INACTIVE INGREDIENT Y27PUL9H56 TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TOBRAMYCIN SOLUTION/ DROPS [AKORN, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TOBRAMYCIN SOLUTION/ DROPS [STAT RX USA LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TOBRAMYCIN SOLUTION/ DROPS [BLENHEIM PHARMACAL, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 17478-290 TOBRAMYCIN SOLUTION/ DROPS [AKORN] 7 Legacy NDC, 4 package rows 20220919_c91db5e0-f6b8-40d7-b307-b24073b9705e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 17478-290-10 17478029010 1 BOTTLE, DROPPER in 1 CARTON (17478-290-10) > 5 mL in 1 BOTTLE, DROPPER 1996-01-31 0000-00-00 No No Current 17478-290-20 17478029020 1 BOTTLE, DROPPER in 1 CARTON (17478-290-20) > 2 mL in 1 BOTTLE, DROPPER 1996-01-31 0000-00-00 No No Current