Home NDC 72603-630 Tobramycin
Product NDC 72603-630
11-digit product format 726030630
Labeler code 72603
Product ID 72603-630_9bb2abbd-9e7c-401e-ab46-4bcbd51c8bd7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler NorthStar RxLLC
Application ANDA216725
Marketing category ANDA
Marketing start 2024-08-01
Substance TOBRAMYCIN
Active strength 300 mg/4mL
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 A216725-001 TOBRAMYCIN TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216725-001 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 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 f41ea6bd6efb…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216725-001 TOBRAMYCIN 300MG/4ML SOLUTION / INHALATION AN 2022-09-22 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/4mL
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 1314763 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 72603-630-04 Tobramycin 4 in 1 POUCH SOLUTION 4 1 72603-630-04 Tobramycin 4 mL in 1 AMPULE SOLUTION 4 1 72603-630-56 Tobramycin 14 in 1 CARTON SOLUTION 14 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72603-630 TOBRAMYCIN SOLUTION [NORTHSTAR RXLLC] 1 Current NDC, 3 package rows 20240802_634efd82-1a35-40cf-9893-50c27d661083.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 · 2 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 72603-630-04 72603063004 4 in 1 POUCH Historical 72603-630-56 72603063056 14 POUCH in 1 CARTON (72603-630-56) / 4 AMPULE in 1 POUCH (72603-630-04) / 4 mL in 1 AMPULE 14 pouch 2024-08-01 No No Current