Home NDC 49502-346 TOBI Podhaler
Product NDC 49502-346
11-digit product format 495020346
Labeler code 49502
Product ID 49502-346_d2aed563-a42a-4345-a710-c13e48b6e6ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Tobramycin
Dosage form CAPSULE
Route ORAL; RESPIRATORY (INHALATION)
Labeler Mylan Specialty L.P.
Application NDA201688
Marketing category NDA
Marketing start 2020-09-24
Marketing end 2023-05-31
Substance TOBRAMYCIN
Active strength 28 mg/1
Pharmacologic classes Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record 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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 Product TE source text 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…
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49502-346-24 49502034624 224 PACKAGE in 1 BOX, UNIT-DOSE (49502-346-24) > 56 BLISTER PACK in 1 PACKAGE > 4 CAPSULE in 1 BLISTER PACK 224 package 2020-09-24 0000-00-00 No No Current 49502-346-57 49502034657 7 BLISTER PACK in 1 BOX, UNIT-DOSE (49502-346-57) > 8 CAPSULE in 1 BLISTER PACK 7 blister pack 2021-07-23 0000-00-00 Yes No Current