Home NDC 65302-063 Tobramycin Inhalation Solution
Product NDC 65302-063
11-digit product format 653020063
Labeler code 65302
Product ID 65302-063_f05e4685-c086-90e3-e053-2995a90a5cd8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler The Ritedose Corporation
Application ANDA201422
Marketing category ANDA
Marketing start 2014-05-29
Marketing end 0000-00-00
Substance TOBRAMYCIN
Active strength 300 mg/5mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 A201422-001 TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A201422-001 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 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A201422-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-05-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tobramycin TOBRAMYCIN Ritedose Pharmaceuticals, LLC e8205898-0162-4e6c-bcf1-87cb074ab9ae 2025-12-10 Warnings, Adverse reactions Exact identifier application applno (ANDA): 201422 application number: ANDA201422
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65302-063-04 65302006304 14 POUCH in 1 CARTON (65302-063-04) > 4 AMPULE in 1 POUCH > 5 mL in 1 AMPULE 14 pouch 2014-05-29 0000-00-00 No No Current