Home NDC 42571-408 Tobramycin
Product NDC 42571-408
11-digit product format 425710408
Labeler code 42571
Product ID 42571-408_38f21173-d355-80a7-e063-6294a90a3643
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin solution
Dosage form INHALANT
Route RESPIRATORY (INHALATION)
Labeler Micro Labs Limited
Application ANDA217344
Marketing category ANDA
Marketing start 2024-01-01
Substance TOBRAMYCIN
Active strength 300 mg/5mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217344-001 TOBRAMYCIN TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217344-001 AN
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 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217344-001 TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2023-07-27 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 300 mg/5mL
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 348719 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 42571-408-09 Tobramycin 5 mL in 1 AMPULE INHALANT 5 3 42571-408-19 Tobramycin 4 in 1 POUCH INHALANT 4 3 42571-408-92 Tobramycin 14 in 1 CARTON INHALANT 14 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42571-408 TOBRAMYCIN (TOBRAMYCIN SOLUTION) INHALANT [MICRO LABS LIMITED] 2 Current NDC, 3 package rows 20240927_9d8b7b6c-3072-48e9-87c8-51160b9df9bc.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 42571-408-09 42571040809 5 mL in 1 AMPULE 5 ml Historical 42571-408-19 42571040819 4 in 1 POUCH Historical 42571-408-92 42571040892 14 POUCH in 1 CARTON (42571-408-92) / 4 AMPULE in 1 POUCH (42571-408-19) / 5 mL in 1 AMPULE (42571-408-09) 14 pouch 2024-01-01 No No Current