Home NDC 0781-7171-56 Tobramycin
Product NDC 0781-7171
Requested package NDC 0781-7171-56
11-digit product format 007817171
Labeler code 0781
Product ID 0781-7171_872e298a-ced7-46d0-8b55-7302faf49e65
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route ORAL
Labeler Sandoz Inc
Application NDA050753
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-07-09
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N050753-001 TOBI TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050753-001 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 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# 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 TOBI TOBRAMYCIN Viatris Specialty LLC 6a3c3871-1d3a-44d6-8be3-526b30123ef7 2025-11-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 050753 application number: NDA050753
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-7171-56 00781717156 56 AMPULE in 1 CARTON (0781-7171-56) > 5 mL in 1 AMPULE (0781-7171-75) 56 ampule 2014-07-09 0000-00-00 No No Current