Home NDC 67457-473-22 Tobramycin
Product NDC 67457-473
Requested package NDC 67457-473-22
11-digit product format 674570473
Labeler code 67457
Product ID 67457-473_7418acd9-03c9-40ed-bac0-1e0702c8114d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Mylan Institutional LLC
Application ANDA065407
Marketing category ANDA
Marketing start 2014-08-19
Substance TOBRAMYCIN SULFATE
Active strength 40 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 A065407-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065407-001 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 · 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 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A065407-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2008-03-11 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 SULFATE 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HJT0RXD7JK Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 597823 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 67457-473-00 Tobramycin 2 mL in 1 VIAL INJECTION 2 7 67457-473-22 Tobramycin 25 in 1 CARTON INJECTION 25 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67457-473 TOBRAMYCIN INJECTION [MYLAN INSTITUTIONAL LLC] 7 Current NDC, Legacy NDC, 2 package rows 20230105_ac8134d9-a726-4508-b8b9-a536ef17243d.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 67457-473-22 67457047322 25 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00) 25 vial 2014-08-19 0000-00-00 No No Current