TOBI Podhaler

Product NDC: 49502-401
Requested package NDC: 49502-401-09
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

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 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49502-401	49502-401-09	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
N201688-001	TOBI PODHALER	TOBRAMYCIN	28MG	POWDER / INHALATION		RLD, RS	2013-03-22

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17
N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N201688-001	TOBI PODHALER	28MG	POWDER / INHALATION	RLD, RS	2013-03-22	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 331 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	7516741	2024-01-11		Drug product	2013-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	RE47526	2024-04-09		Drug product	2020-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	11484671	2024-11-07	U-909	Drug product	2022-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	7516741	2024-01-11		Drug product	2013-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	RE47526	2024-04-09		Drug product	2020-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	11484671	2024-11-07	U-909	Drug product	2022-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	7516741	2024-01-11		Drug product	2013-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	RE47526	2024-04-09		Drug product	2020-06-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	11484671	2024-11-07	U-909	Drug product	2022-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	8664187	2025-06-20	U-909		2019-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	7559325	2025-10-27		Drug product	2013-04-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	8869794	2028-09-12	U-909	Drug product	2019-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201688-001	10207066	2030-11-04	U-909	Drug product	2019-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N201688-001	7516741	2024-01-11		Drug product	2013-04-19	`d8e5a09893c0…`

Additional Listing Data#

Finished product: Yes
Brand name base: TOBI Podhaler
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TOBRAMYCIN	28 mg/1

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 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1374569	Internal RxNorm lookup
1374570	Internal RxNorm lookup
1374573	Internal RxNorm lookup
1374574	Internal RxNorm lookup
1661466	Internal RxNorm lookup
1661559	Internal RxNorm lookup
1661560	Internal RxNorm lookup
1661567	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
c4b5bb1f-e158-4ac1-9c35-e98a416c743a	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
f297c7c1-845a-4369-8c02-c51b92d6ae8e	Product name	3	20240725
551d952d-4ce2-24f0-9ab0-630ad9aae596	Product name	2	20231211
941f67d9-7f03-56d2-750c-36de24f654db	Product name	3	20221117
9cfa145f-dbe9-bc02-83c2-692786ef6676	Product name	9	20210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796	Product name	4	20210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277	Product name	4	20210625
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
9f5124fb-08b0-4c3e-8e12-a1a6ff310cba	Product name	1	20150309
745a62af-e1c0-4ca3-6d6e-2b6455b903be	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
9ea85abb-fa68-5da6-ab60-2c7eef579000	Product name	1	20140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
d029211e-5e6b-725f-3696-ac6ff77da222	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
49502-401-08	TOBI Podhaler	8 in 1 BOX, UNIT-DOSE	CAPSULE	8	12
49502-401-09	TOBI Podhaler	8 in 1 BOX, UNIT-DOSE	CAPSULE	8	12
49502-401-24	TOBI Podhaler	224 in 1 BOX, UNIT-DOSE	CAPSULE	224	12
49502-401-24	TOBI Podhaler	56 in 1 PACKAGE	CAPSULE	56	12
49502-401-56	TOBI Podhaler	56 in 1 BOX, UNIT-DOSE	CAPSULE	56	12
49502-401-57	TOBI Podhaler	7 in 1 BOX, UNIT-DOSE	CAPSULE	7	12
49502-401-57	TOBI Podhaler	8 in 1 BLISTER PACK	CAPSULE	8	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49502-401-24	EA - Each	49502-401	619d7471-490d-456a-bfba-30a23b9ca8e3	1	2021-09-07
49502-401-56	EA - Each	49502-401	e4e6cc8f-c2ed-4c04-b8dd-7e30c20e532a	1	2021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49502-401	TOBI PODHALER (TOBRAMYCIN) CAPSULE [VIATRIS SPECIALTY LLC]	10	Current NDC, Legacy NDC, 7 package rows	20250213_c4b5bb1f-e158-4ac1-9c35-e98a416c743a.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TOBI Podhaler	TOBRAMYCIN	Viatris Specialty LLC	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 201688 application number: NDA201688 ndc (package): 49502-401-09 ndc (product): 49502-401 ndc11 (package): 49502040109

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
VZ8RRZ51VK	TOBRAMYCIN	32986-56-4	TOBRAMYCIN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1374574	{224 (tobramycin 28 MG Inhalation Powder [Tobi]) } Pack [TOBI Podhaler Kit]	BPCK	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661560	{56 (tobramycin 28 MG Inhalation Powder [Tobi]) } Pack [TOBI Podhaler Weekly Kit]	BPCK	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661567	{8 (tobramycin 28 MG Inhalation Powder [Tobi]) } Pack [TOBI Podhaler Daily Kit]	BPCK	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374570	{224 (tobramycin 28 MG Inhalation Powder) } Pack	GPCK	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661559	{56 (tobramycin 28 MG Inhalation Powder) } Pack	GPCK	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661466	{8 (tobramycin 28 MG Inhalation Powder) } Pack	GPCK	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374573	Tobi 28 MG Inhalation Powder Capsule	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374574	TOBI Podhaler 224 Capsule Monthly Pack	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661560	TOBI Podhaler 56 Capsule Weekly Pack	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661567	TOBI Podhaler 8 Capsule Daily Pack	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374570	tobramycin 28 MG inhalation powder 224 Monthly Pack	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661559	tobramycin 28 MG inhalation powder 56 Weekly Pack	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661466	tobramycin 28 MG inhalation powder 8 Daily Pack	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374569	tobramycin 28 MG Inhalation Powder Capsule	PSN	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374573	tobramycin 28 MG Inhalation Powder [Tobi]	SBD	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374569	tobramycin 28 MG Inhalation Powder	SCD	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374573	Tobi 28 MG Inhalation Powder	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661567	TOBI Podhaler Daily Kit, 8	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661567	TOBI Podhaler Daily Kit, including 8 capsules (1 Blister Card of 8 Capsules)	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374574	TOBI Podhaler Kit, 224	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374574	TOBI Podhaler Kit, 4 Weekly Packs, each including 56 capsules (7 Blister Cards of 8 Capsules)	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661560	TOBI Podhaler Weekly Kit, 56	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1661560	TOBI Podhaler Weekly Kit, including 56 capsules (7 Blister Cards of 8 Capsules)	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12
1374569	tobramcyin 28 MG Inhalation Powder	SY	c4b5bb1f-e158-4ac1-9c35-e98a416c743a	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49502-401-09	49502040109	8 CAPSULE in 1 BOX, UNIT-DOSE (49502-401-09)	8 capsule	2022-10-04	2025-06-30	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TOBI Podhaler - Viatris Specialty LLC	Viatris Specialty LLC	2026-04-15	HUMAN PRESCRIPTION DRUG LABEL	13