Home NDC 63323-303 Tobramycin
Product NDC 63323-303
11-digit product format 633230303
Labeler code 63323
Product ID 63323-303_473ebf35-f2d4-46fb-9463-3fe402309c01
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOBRAMYCIN SULFATE
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application NDA050789
Marketing category NDA
Marketing start 2005-11-23
Substance TOBRAMYCIN SULFATE
Active strength 1200 mg/30mL
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 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 N050789-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050789-001 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 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050789-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2004-07-13 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 1200 mg/30mL
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 63323-303-01 Tobramycin 30 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 30 7 63323-303-51 Tobramycin 6 in 1 TRAY INJECTION, POWDER, FOR SOLUTION 6 7 63323-303-21 Tobramycin 30 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, FOR SOLUTION 30 3 63323-303-55 Tobramycin 6 in 1 TRAY INJECTION, POWDER, FOR SOLUTION 6 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63323-303 TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 7 Current NDC, Legacy NDC, 2 package rows 20240130_d62ff359-912b-4be1-9fc2-2dde8777eefb.zip 63323-303 TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, POWDER, FOR SOLUTION [FRESENIUS KABI USA, LLC
] 3 Current NDC, Legacy NDC, 2 package rows 20240214_9a5cecd6-aa65-42d2-b15a-06b4fcebcc0f.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 · 2 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 63323-303-01 63323030301 30 mL in 1 VIAL, PHARMACY BULK PACKAGE 30 ml Historical 63323-303-21 63323030321 30 mL in 1 VIAL, PHARMACY BULK PACKAGE 30 ml Historical 63323-303-51 63323030351 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-01) 2005-11-23 0000-00-00 No No Current 63323-303-55 63323030355 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-55) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-21) 2005-11-23 0000-00-00 No No Current