Home NDC 68083-253 Tobramycin
Product NDC 68083-253
11-digit product format 680830253
Labeler code 68083
Product ID 68083-253_5af7f80d-4d6d-404f-9ff7-1a8315625d8b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION
Route INTRAMUSCULAR; INTRAVENOUS
Labeler Gland Pharma Limited
Application ANDA209621
Marketing category ANDA
Marketing start 2021-02-11
Substance TOBRAMYCIN SULFATE
Active strength 10 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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209621-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 A209621-002 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 · 68 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 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209621-001 TOBRAMYCIN SULFATE EQ 10MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 87673890dc5c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A209621-002 TOBRAMYCIN SULFATE EQ 40MG BASE/ML INJECTABLE / INJECTION AP 2021-02-11 87673890dc5c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 68 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 10 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 313416 Internal RxNorm lookup 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 68083-253-01 Tobramycin 2 mL in 1 VIAL, MULTI-DOSE INJECTION 2 7 68083-253-25 Tobramycin 25 in 1 CARTON INJECTION 25 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-253 TOBRAMYCIN INJECTION [GLAND PHARMA LIMITED] 7 Current NDC, Legacy NDC, 2 package rows 20230310_645d34d9-275d-428e-863d-ae15ad009c44.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 68083-253-01 68083025301 2 mL in 1 VIAL, MULTI-DOSE 2 ml Historical 68083-253-25 68083025325 25 VIAL, MULTI-DOSE in 1 CARTON (68083-253-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-253-01) 2021-02-11 0000-00-00 No No Current