Home NDC 72266-163 Tobramycin
Product NDC 72266-163
11-digit product format 722660163
Labeler code 72266
Product ID 72266-163_1c499644-6570-e991-e063-6394a90a7b6c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler Fosun Pharma USA Inc
Application ANDA211189
Marketing category ANDA
Marketing start 2021-08-11
Substance TOBRAMYCIN SULFATE
Active strength 1.2 g/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 A211189-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211189-001 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 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211189-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2021-05-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Tobramycin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOBRAMYCIN SULFATE 1.2 g/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 72266-163-01 Tobramycin 30 mL in 1 VIAL, PHARMACY BULK PACKAGE INJECTION, POWDER, LYOPHILIZED, 30 3 72266-163-06 Tobramycin 6 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 6 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72266-163 TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FOSUN PHARMA USA INC] 3 Current NDC, Legacy NDC, 2 package rows 20240704_c4751a4f-c9c1-60c5-e053-2995a90aeba9.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Tobramycin TOBRAMYCIN Xiromed LLC 8b50d1b5-ea8a-5844-358a-493f1965c07f 2026-02-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211189 application number: ANDA211189 Tobramycin TOBRAMYCIN Northstar Rx LLC 55d09ffd-4f32-8aeb-3904-8a17db635e3a 2025-09-23 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211189 application number: ANDA211189 Tobramycin TOBRAMYCIN Fosun Pharma USA Inc c4751a4f-c9c1-60c5-e053-2995a90aeba9 2022-12-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211189 application number: ANDA211189 ndc (product): 72266-163 Tobramycin TOBRAMYCIN Gland Pharma Limited 38219f34-4859-428f-9ec1-06ead7604211 2022-10-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211189 application number: ANDA211189
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 72266-163-01 72266016301 30 mL in 1 VIAL, PHARMACY BULK PACKAGE 30 ml Historical 72266-163-06 72266016306 6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72266-163-06) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (72266-163-01) 2021-08-11 0000-00-00 No No Current