Home NDC 63187-973 Tobramycin
Product NDC 63187-973
11-digit product format 631870973
Labeler code 63187
Product ID 63187-973_3439b089-5661-47e1-87e9-7b18c7d61540
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route OPHTHALMIC
Labeler Proficient Rx LP
Application ANDA062535
Marketing category ANDA
Marketing start 1995-01-09
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 A062535-001 TOBREX TOBRAMYCIN 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A062535-001 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 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A062535-001 TOBREX 0.3% SOLUTION/DROPS / OPHTHALMIC AT 1984-12-13 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
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 63187-973-05 Tobramycin 5 mL in 1 BOTTLE, PLASTIC SOLUTION 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-973 TOBRAMYCIN SOLUTION [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 1 package rows 20191105_4eb4dfd1-f3ae-4400-b043-910b4c77296b.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 63187-973-05 63187097305 5 mL in 1 BOTTLE, PLASTIC (63187-973-05) 5 ml 2018-01-01 0000-00-00 No No Current