Home NDC 65162-914 Tobramycin
Product NDC 65162-914
11-digit product format 651620914
Labeler code 65162
Product ID 65162-914_609a53df-fb3c-4349-8ada-22b985d2c4ac
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Amneal Pharmaceuticals LLC
Application ANDA205501
Marketing category ANDA
Marketing start 2014-07-13
Substance TOBRAMYCIN
Active strength 300 mg/5mL
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 A205501-001 TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205501-001 AN
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 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205501-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2015-07-13 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 300 mg/5mL
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 348719 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 65162-914-46 Tobramycin 56 in 1 CARTON SOLUTION 56 24 65162-914-46 Tobramycin 5 mL in 1 AMPULE SOLUTION 5 24
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-914 TOBRAMYCIN SOLUTION [AMNEAL PHARMACEUTICALS LLC] 24 Current NDC, Legacy NDC, 2 package rows 20241031_15f9c0cd-7dbf-4a91-9961-14f1dd000343.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 Units Marketing start Marketing end Sample Exclude flag Status 65162-914-46 65162091446 56 AMPULE in 1 CARTON (65162-914-46) / 5 mL in 1 AMPULE 56 ampule 2014-07-13 0000-00-00 No No Current