Home NDC 36000-242 Tobramycin
Product NDC 36000-242
11-digit product format 360000242
Labeler code 36000
Product ID 36000-242_19ade85b-3da4-44af-8ad0-d68d15a48193
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Baxter Healthcare Corporation
Application ANDA206965
Marketing category ANDA
Marketing start 2016-07-15
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 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 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A206965-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A206965-001 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 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A206965-001 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2016-07-01 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# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36000-242 TOBRAMYCIN INJECTION [BAXTER HEALTHCARE CORPORATION] 15 Current NDC, Legacy NDC, 6 package rows 20240922_a9897444-71f6-42af-9b71-4aa77829ade0.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 36000-242-01 36000024201 1 VIAL, MULTI-DOSE in 1 CARTON (36000-242-01) / 30 mL in 1 VIAL, MULTI-DOSE 2016-07-15 0000-00-00 No No Current 36000-242-05 36000024205 30 mL in 1 VIAL 30 ml Historical 36000-242-10 36000024210 10 in 1 CARTON Historical