Home NDC 68083-374 Tobramycin
Product NDC 68083-374
11-digit product format 680830374
Labeler code 68083
Product ID 68083-374_f43b227e-3e24-428d-bef1-4f32628a786e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Gland Pharma Limited
Application ANDA212628
Marketing category ANDA
Marketing start 2021-03-09
Substance TOBRAMYCIN
Active strength 3 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
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 A212628-001 TOBRAMYCIN TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212628-001 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 2026-02-19 14:30 UTC 2026-02 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212628-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2021-03-09 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tobramycin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOBRAMYCIN 3 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZ8RRZ51VK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313415 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 68083-374-01 Tobramycin 5 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 5 7 68083-374-01 Tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-374 TOBRAMYCIN SOLUTION/ DROPS [GLAND PHARMA LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20210728_f8c92d73-711a-423f-bf34-bdec4464828e.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 · 3 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 68083-374-01 68083037401 1 BOTTLE, PLASTIC in 1 CARTON (68083-374-01) / 5 mL in 1 BOTTLE, PLASTIC 2021-03-09 0000-00-00 No No Current