Home NDC 70644-899 Tobramycin
Product NDC 70644-899
11-digit product format 706440899
Labeler code 70644
Product ID 70644-899_aeeb7c89-484f-4429-a5d5-0025d19745fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Genericus, Inc.
Application NDA205433
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2016-07-11
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 N205433-001 KITABIS PAK TOBRAMYCIN 300MG/5ML SOLUTION / INHALATION AN 2014-12-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N205433-001 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 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205433-001 KITABIS PAK 300MG/5ML SOLUTION / INHALATION AN 2014-12-02 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 Tobramycin
Brand name suffix Inhalation Solution Pak
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 70644-899-99 TobramycinInhalation Solution Pak 14 in 1 CARTON SOLUTION 14 9 70644-899-99 TobramycinInhalation Solution Pak 4 in 1 POUCH SOLUTION 4 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70644-899 TOBRAMYCIN INHALATION SOLUTION PAK (TOBRAMYCIN) SOLUTION [GENERICUS, INC.
] 9 Current NDC, Legacy NDC, 2 package rows 20250104_dad13445-f591-4829-96f9-1598ba03dff8.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 Marketing end Sample Exclude flag Status 70644-899-99 70644089999 14 POUCH in 1 CARTON (70644-899-99) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE 14 pouch 2016-07-11 0000-00-00 No No Current