Home NDC 49502-345 TOBI
Product NDC 49502-345
11-digit product format 495020345
Labeler code 49502
Product ID 49502-345_99c630df-5e03-4944-8225-26940d0ae737
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route ORAL; RESPIRATORY (INHALATION)
Labeler Viatris Specialty LLC
Application NDA050753
Marketing category NDA
Marketing start 2022-06-23
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 N050753-001 TOBI TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N050753-001 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.
Product history page 1 of 2 · 41 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 2026-02-19 14:30 UTC 2026-02 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N050753-001 TOBI 300MG/5ML SOLUTION / INHALATION AN RLD, RS 1997-12-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base TOBI
Listing expiration 2027-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 213194 Internal RxNorm lookup 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 49502-345-73 TOBI 56 in 1 CARTON SOLUTION 56 6 49502-345-99 TOBI 4 in 1 POUCH SOLUTION 4 6 49502-345-99 TOBI 5 mL in 1 AMPULE SOLUTION 5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49502-345 TOBI (TOBRAMYCIN) SOLUTION [VIATRIS SPECIALTY LLC] 6 Current NDC, Legacy NDC, 3 package rows 20250213_6a3c3871-1d3a-44d6-8be3-526b30123ef7.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 49502-345-73 49502034573 56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE 56 pouch 2022-06-23 0000-00-00 No No Current 49502-345-74 49502034574 56 POUCH in 1 CARTON (49502-345-74) / 14 AMPULE in 1 POUCH (49502-345-01) / 5 mL in 1 AMPULE 56 pouch 2026-06-25 0 Current 49502-345-99 49502034599 4 in 1 POUCH Historical