FDA.reportPublic FDA data

TOBI Podhaler

Product NDC
49502-401
11-digit product format
495020401
Labeler code
49502
Product ID
49502-401_0ebb786f-98a7-47b4-a0ef-06c0412ca3da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tobramycin
Dosage form
CAPSULE
Route
ORAL; RESPIRATORY (INHALATION)
Labeler
Viatris Specialty LLC
Application
NDA201688
Marketing category
NDA
Marketing start
2021-09-01
Substance
TOBRAMYCIN
Active strength
28 mg/1
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
TOBI Podhaler
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOBRAMYCIN28 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVZ8RRZ51VK
Rxcui1374569, 1374570, 1374573, 1374574, 1661466, 1661559, 1661560, 1661567

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
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
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-401-08TOBI Podhaler8 in 1 BOX, UNIT-DOSECAPSULE812
49502-401-09TOBI Podhaler8 in 1 BOX, UNIT-DOSECAPSULE812
49502-401-24TOBI Podhaler224 in 1 BOX, UNIT-DOSECAPSULE22412
49502-401-24TOBI Podhaler56 in 1 PACKAGECAPSULE5612
49502-401-56TOBI Podhaler56 in 1 BOX, UNIT-DOSECAPSULE5612
49502-401-57TOBI Podhaler7 in 1 BOX, UNIT-DOSECAPSULE712
49502-401-57TOBI Podhaler8 in 1 BLISTER PACKCAPSULE812

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-401-24EA - Each49502-401619d7471-490d-456a-bfba-30a23b9ca8e312021-09-07
49502-401-56EA - Each49502-401e4e6cc8f-c2ed-4c04-b8dd-7e30c20e532a12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-401TOBI PODHALER (TOBRAMYCIN) CAPSULE [VIATRIS SPECIALTY LLC]10Current NDC, Legacy NDC, 7 package rows20250213_c4b5bb1f-e158-4ac1-9c35-e98a416c743a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1374574{224 (tobramycin 28 MG Inhalation Powder [Tobi]) } Pack [TOBI Podhaler Kit]BPCKc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661560{56 (tobramycin 28 MG Inhalation Powder [Tobi]) } Pack [TOBI Podhaler Weekly Kit]BPCKc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661567{8 (tobramycin 28 MG Inhalation Powder [Tobi]) } Pack [TOBI Podhaler Daily Kit]BPCKc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374570{224 (tobramycin 28 MG Inhalation Powder) } PackGPCKc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661559{56 (tobramycin 28 MG Inhalation Powder) } PackGPCKc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661466{8 (tobramycin 28 MG Inhalation Powder) } PackGPCKc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374573Tobi 28 MG Inhalation Powder CapsulePSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374574TOBI Podhaler 224 Capsule Monthly PackPSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661560TOBI Podhaler 56 Capsule Weekly PackPSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661567TOBI Podhaler 8 Capsule Daily PackPSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374570tobramycin 28 MG inhalation powder 224 Monthly PackPSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661559tobramycin 28 MG inhalation powder 56 Weekly PackPSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661466tobramycin 28 MG inhalation powder 8 Daily PackPSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374569tobramycin 28 MG Inhalation Powder CapsulePSNc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374573tobramycin 28 MG Inhalation Powder [Tobi]SBDc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374569tobramycin 28 MG Inhalation PowderSCDc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374573Tobi 28 MG Inhalation PowderSYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661567TOBI Podhaler Daily Kit, 8SYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661567TOBI Podhaler Daily Kit, including 8 capsules (1 Blister Card of 8 Capsules)SYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374574TOBI Podhaler Kit, 224SYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374574TOBI Podhaler Kit, 4 Weekly Packs, each including 56 capsules (7 Blister Cards of 8 Capsules)SYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661560TOBI Podhaler Weekly Kit, 56SYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1661560TOBI Podhaler Weekly Kit, including 56 capsules (7 Blister Cards of 8 Capsules)SYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12
1374569tobramcyin 28 MG Inhalation PowderSYc4b5bb1f-e158-4ac1-9c35-e98a416c743a12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49502-401-08495020401088 in 1 BOX, UNIT-DOSEHistorical
49502-401-09495020401098 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09) 8 capsule2022-10-042025-06-30YesNoCurrent
49502-401-2449502040124224 PACKAGE in 1 BOX, UNIT-DOSE (49502-401-24) / 56 BLISTER PACK in 1 PACKAGE / 4 CAPSULE in 1 BLISTER PACK224 package2021-09-012026-12-31NoNoCurrent
49502-401-564950204015656 in 1 BOX, UNIT-DOSEHistorical
49502-401-57495020401577 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-401-57) / 8 CAPSULE in 1 BLISTER PACK7 blister pack2022-10-042025-06-30YesNoCurrent