Home NDC 62332-518 Tobramycin Ophthalmic Solution
Product NDC 62332-518
11-digit product format 623320518
Labeler code 62332
Product ID 62332-518_5d11cea7-cb06-4ab9-930d-190549b2f4ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin Ophthalmic Solution
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Alembic Pharmaceuticals Inc.
Application ANDA211847
Marketing category ANDA
Marketing start 2019-04-19
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 A211847-001 TOBRAMYCIN TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211847-001 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 · 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 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211847-001 TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 2019-04-19 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Tobramycin Ophthalmic Solution
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 62332-518-05 Tobramycin Ophthalmic Solution 1 in 1 CARTON SOLUTION/ DROPS 1 9 62332-518-05 Tobramycin Ophthalmic Solution 5 mL in 1 BOTTLE SOLUTION/ DROPS 5 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62332-518 TOBRAMYCIN OPHTHALMIC SOLUTION SOLUTION/ DROPS [ALEMBIC PHARMACEUTICALS INC.] 9 Current NDC, Legacy NDC, 2 package rows 20240616_3c23234a-452b-40d0-922f-37e49147d537.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62332-518-05 62332051805 1 BOTTLE in 1 CARTON (62332-518-05) / 5 mL in 1 BOTTLE 1 bottle 2019-04-19 0000-00-00 No No Current