Home NDC 70436-110 tobramycin
Product NDC 70436-110
11-digit product format 704360110
Labeler code 70436
Product ID 70436-110_4a830833-6027-9c0a-e063-6394a90a27ee
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tobramycin
Dosage form INJECTION, POWDER, FOR SOLUTION
Route INTRAVENOUS
Labeler Slate Run Pharmaceuticals, LLC
Application ANDA217029
Marketing category ANDA
Marketing start 2023-02-01
Substance TOBRAMYCIN
Active strength 1200 mg/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 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 A217029-001 TOBRAMYCIN SULFATE TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217029-001 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 2026-02-19 14:30 UTC 2026-02 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217029-001 TOBRAMYCIN SULFATE EQ 1.2GM BASE/VIAL INJECTABLE / INJECTION AP 2023-02-01 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 1200 mg/30mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VZ8RRZ51VK 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 70436-110-36 tobramycin 30 mL in 1 VIAL INJECTION, POWDER, FOR SOLUTION 30 4 70436-110-56 tobramycin 180 mL in 1 CARTON INJECTION, POWDER, FOR SOLUTION 180 4 70436-110-80 tobramycin 30 mL in 1 CARTON INJECTION, POWDER, FOR SOLUTION 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70436-110 TOBRAMYCIN INJECTION, POWDER, FOR SOLUTION [SLATE RUN PHARMACEUTICALS, LLC] 3 Current NDC, 3 package rows 20231109_ed254eec-10f4-425a-895b-66e325b7bf69.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 Sample Exclude flag Status 70436-110-36 70436011036 30 mL in 1 VIAL (70436-110-36) 30 ml 2023-02-01 No No Current 70436-110-56 70436011056 180 mL in 1 CARTON (70436-110-56) 180 ml 2023-02-01 No No Current 70436-110-80 70436011080 30 mL in 1 CARTON (70436-110-80) 30 ml 2023-12-01 No No Current