FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
Kitabis Pak
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN300 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui348719, 1596030

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
24492-850-562024-12-11C16284748780-11030e365-1f14-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use KITABIS ® PAK safely and effectively. See full prescribing information for KITABIS PAK. KITABIS PAK (tobramycin inhalation solution), for oral inhalation use Initial U.S. Approval: 1975
24492-850-562024-07-30C16284748780-11030e365-1f14-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use KITABIS ® PAK safely and effectively. See full prescribing information for KITABIS PAK. KITABIS PAK (tobramycin inhalation solution), for oral inhalation use Initial U.S. Approval: 1975
24492-850-562024-01-30C16284748780-11030e365-1f14-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use KITABIS ® PAK safely and effectively. See full prescribing information for KITABIS PAK. KITABIS PAK (tobramycin inhalation solution), for oral inhalation use Initial U.S. Approval: 1975

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24492-850-56Kitabis Pak14 in 1 CARTONSOLUTION1410
24492-850-56Kitabis Pak4 in 1 POUCHSOLUTION410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24492-850-56ML - Milliliter24492-850129f20b9-2464-4bc7-bf32-2a45d9cfbdbd12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TobramycinACTIVE INGREDIENTVZ8RRZ51VKKITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT]3
TobramycinACTIVE MOIETYVZ8RRZ51VKKITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT]3
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XKITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT]3
Sulfuric AcidINACTIVE INGREDIENTO40UQP6WCFKITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT]3
WaterINACTIVE INGREDIENT059QF0KO0RKITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24492-850KITABIS PAK (TOBRAMYCIN) SOLUTION [PARI RESPIRATORY EQUIPMENT, INC.]10Current NDC, Legacy NDC, 2 package rows20241213_da1e5afd-d707-4af1-8935-8195ba6d769f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596030Kitabis 300 MG in 5 ML Inhalation SolutionPSNda1e5afd-d707-4af1-8935-8195ba6d769f10
348719tobramycin 300 MG in 5 ML Inhalation SolutionPSNda1e5afd-d707-4af1-8935-8195ba6d769f10
1596030tobramycin 60 MG/ML Inhalation Solution [Kitabis]SBDda1e5afd-d707-4af1-8935-8195ba6d769f10
348719tobramycin 60 MG/ML Inhalation SolutionSCDda1e5afd-d707-4af1-8935-8195ba6d769f10
1596030Kitabis 300 MG per 5 ML Inhalation SolutionSYda1e5afd-d707-4af1-8935-8195ba6d769f10
1596030Kitabis 60 MG/ML Inhalation SolutionSYda1e5afd-d707-4af1-8935-8195ba6d769f10
348719tobramycin 300 MG per 5 ML Inhalation SolutionSYda1e5afd-d707-4af1-8935-8195ba6d769f10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24492-850-562449208505614 POUCH in 1 CARTON (24492-850-56) / 4 AMPULE in 1 POUCH / 5 mL in 1 AMPULE14 pouch2015-02-190000-00-00NoNoCurrent