Home NDC 39822-0412 Tobramycin
Product NDC 39822-0412
11-digit product format 398220412
Labeler code 39822
Product ID 39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route INTRAVENOUS
Labeler XGen Pharmaceuticals DJB, Inc.
Application ANDA065013
Marketing category ANDA
Marketing start 2001-08-17
Substance TOBRAMYCIN SULFATE
Active strength 1.2 g/30mL
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 43 .
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 A065013-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A065013-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A065013-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP RS 2001-08-17 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 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 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 39822-0412-1 Tobramycin 1 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 1 27 39822-0412-1 Tobramycin 30 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 30 27 39822-0412-6 Tobramycin 6 in 1 CARTON INJECTION, POWDER, LYOPHILIZED, 6 27 39822-0412-6 Tobramycin 30 mL in 1 VIAL INJECTION, POWDER, LYOPHILIZED, 30 27
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOBRAMYCIN SULFATE ACTIVE INGREDIENT HJT0RXD7JK TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 16 TOBRAMYCIN ACTIVE MOIETY VZ8RRZ51VK TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [X-GEN PHARMACEUTICALS, INC.] 16
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 39822-0412 TOBRAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [XGEN PHARMACEUTICALS DJB, INC.] 26 Current NDC, Legacy NDC, 4 package rows 20230328_a384641c-04e3-4ab5-b152-7408cd07b64d.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 39822-0412-1 39822041201 1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL 1 vial 2001-08-17 0000-00-00 No No Current 39822-0412-6 39822041206 6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL 6 vial 2001-08-17 0000-00-00 No No Current