Home NDC 45932-0027 Tobramycin
Product NDC 45932-0027
11-digit product format 459320027
Labeler code 45932
Product ID 45932-0027_9fa8b06d-a006-420c-93cb-89053b1564a1
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Xellia Pharmaceuticals ApS
Application ANDA205685
Marketing category ANDA
Marketing start 2014-04-10
Marketing end 0000-00-00
Substance TOBRAMYCIN SULFATE
Active strength 1200 mg/30mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2019-12-31
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 · 54 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45932-0027-2 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 45932-0027-1 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45932-0027-2 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 45932-0027-1 D Discontinued by firm f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45932-0027-2 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 45932-0027-1 D Discontinued by firm 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45932-0027-2 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 45932-0027-1 D Discontinued by firm a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45932-0027-2 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 45932-0027-1 D Discontinued by firm cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45932-0027-2 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 45932-0027-1 D Discontinued by firm cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45932-0027-2 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 45932-0027-1 D Discontinued by firm 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45932-0027-2 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 45932-0027-1 D Discontinued by firm ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45932-0027-2 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 45932-0027-1 D Discontinued by firm 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 45932-0027-2 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 45932-0027-1 D Discontinued by firm ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 45932-0027-2 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 45932-0027-1 D Discontinued by firm 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 45932-0027-2 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 45932-0027-1 D Discontinued by firm 557ba5c1ecfa…9c80585c8c6e…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 45932-0027-1 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 45932-0027-2 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 45932-0027-1 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 45932-0027-2 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 45932-0027-1 I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 45932-0027-2 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 45932-0027-1 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 45932-0027-2 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 45932-0027-1 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 45932-0027-2 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 45932-0027-1 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 45932-0027-2 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A205685-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205685-001 AP
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 · 42 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 2026-08-18 06:07:40 2026-07 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205685-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2014-09-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
FDA-Initiated Inactive NDC Indexing# NDC, Effective, Related label table NDC Effective Related label 45932-0027-1 2023-02-24 Rx ONLY This bottle is intended for use by the hospital pharmacist in the extemporaneous preparation of intravenous solutions. PHARMACY BULK PACKAGE Not for direct infusion To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection, and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 45932-0027-2 2023-02-24 Rx ONLY This bottle is intended for use by the hospital pharmacist in the extemporaneous preparation of intravenous solutions. PHARMACY BULK PACKAGE Not for direct infusion To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection, and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 45932-0027-1 2020-01-31 Rx ONLY This bottle is intended for use by the hospital pharmacist in the extemporaneous preparation of intravenous solutions. PHARMACY BULK PACKAGE Not for direct infusion To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection, and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. 45932-0027-2 2020-01-31 Rx ONLY This bottle is intended for use by the hospital pharmacist in the extemporaneous preparation of intravenous solutions. PHARMACY BULK PACKAGE Not for direct infusion To reduce the development of drug-resistant bacteria and maintain the effectiveness of Tobramycin for Injection, and other antibacterial drugs, tobramycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.