Home NDC 68083-241 Tobramycin
Product NDC 68083-241
11-digit product format 680830241
Labeler code 68083
Product ID 68083-241_7dec68fc-8f9a-4a26-9578-81bb22a5a1b5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION
Route INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA209346
Marketing category ANDA
Marketing start 2021-02-09
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 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 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A209346-001 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.
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 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209346-001 TOBRAMYCIN SULFATE (PHARMACY BULK) EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-09 a50c72e98297…
Observed Orange Book normalized TE history# 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 68083-241-01 Tobramycin 1 in 1 CARTON INJECTION 1 7 68083-241-01 Tobramycin 50 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION 50 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-241 TOBRAMYCIN INJECTION [GLAND PHARMA LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20230228_02b48684-168c-4cd9-8375-794206eff23e.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 Marketing start Marketing end Sample Exclude flag Status 68083-241-01 68083024101 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68083-241-01) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE 2021-02-09 0000-00-00 No No Current