Home NDC 24492-850 Kitabis Pak
Product NDC 24492-850
11-digit product format 244920850
Labeler code 24492
Product ID 24492-850_49aa9935-4371-43a5-a681-f7a5725b1b2b
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form SOLUTION
Route RESPIRATORY (INHALATION)
Labeler Pari Respiratory Equipment, Inc.
Application NDA205433
Marketing category NDA
Marketing start 2015-02-19
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 24492-850-56 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 24492-850-56 367a005e9d99…383a685ebd0f…
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 Kitabis 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 348719 Internal RxNorm lookup 1596030 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 24492-850-56 Kitabis Pak 14 in 1 CARTON SOLUTION 14 10 24492-850-56 Kitabis Pak 4 in 1 POUCH SOLUTION 4 10
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24492-850 KITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT, INC.] 10 Current NDC, Legacy NDC, 2 package rows 20241213_da1e5afd-d707-4af1-8935-8195ba6d769f.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 24492-850-56 24492085056 14 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE 14 pouch 2015-02-19 0000-00-00 No No Current