Home NDC 0409-3578 TOBRAMYCIN
Product NDC 0409-3578
11-digit product format 004093578
Labeler code 0409
Product ID 0409-3578_d69232fd-aeae-44b9-9e43-2f2e5bd843be
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TOBRAMYCIN
Dosage form INJECTION, SOLUTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Hospira, Inc.
Application ANDA063111
Marketing category ANDA
Marketing start 2005-05-05
Substance TOBRAMYCIN SULFATE
Active strength 40 mg/mL
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
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 A063111-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A063111-001 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 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A063111-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 1991-04-30 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 2027-12-31 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 0409-3578-01 TOBRAMYCIN 25 in 1 TRAY INJECTION, SOLUTION 25 22 0409-3578-11 TOBRAMYCIN 2 mL in 1 VIAL, MULTI-DOSE INJECTION, SOLUTION 2 22
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOBRAMYCIN SULFATE ACTIVE INGREDIENT HJT0RXD7JK TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.] 12 TOBRAMYCIN ACTIVE MOIETY VZ8RRZ51VK TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.] 12 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM HYDROXIDE INACTIVE INGREDIENT 55X04QC32I TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.] 12 SODIUM METABISULFITE INACTIVE INGREDIENT 4VON5FNS3C TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.] 12 SULFURIC ACID INACTIVE INGREDIENT O40UQP6WCF TOBRAMYCIN (TOBRAMYCIN SULFATE) INJECTION, SOLUTION [HOSPIRA, INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0409-3578 TOBRAMYCIN INJECTION, SOLUTION [HOSPIRA, INC.] 21 Current NDC, Legacy NDC, 2 package rows 20241212_c5a005b0-7b6f-4e30-df92-9a20b1ca66a1.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 0409-3578-01 00409357801 25 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01) / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11) 2005-05-05 0000-00-00 No No Current 0409-3578-11 00409357811 2 mL in 1 VIAL, MULTI-DOSE 2 ml Historical