Home NDC 63187-902 Tobramycin
Product NDC 63187-902
11-digit product format 631870902
Labeler code 63187
Product ID 63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Proficient Rx LP
Application ANDA064096
Marketing category ANDA
Marketing start 1996-01-31
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 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# 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 63187-902-02 Tobramycin 2 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2 3 63187-902-02 Tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 3 63187-902-05 Tobramycin 1 in 1 CARTON SOLUTION/ DROPS 1 3 63187-902-05 Tobramycin 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-902 TOBRAMYCIN SOLUTION/ DROPS [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 4 package rows 20191108_ac497300-eb1e-4021-b504-89f19e1eb0f3.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 63187-902-02 63187090202 1 BOTTLE, DROPPER in 1 CARTON (63187-902-02) / 2 mL in 1 BOTTLE, DROPPER 2017-09-01 0000-00-00 No No Current 63187-902-05 63187090205 1 BOTTLE, DROPPER in 1 CARTON (63187-902-05) / 5 mL in 1 BOTTLE, DROPPER 2017-09-01 0000-00-00 No No Current