National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2013-05-02
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 04:07:31
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 59676-701-01 | EA - Each | 59676-701 | 7778105e-e2fb-46f2-b8b6-26d84e656e65 | 1 | 2013-05-02 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 59676-701 | 59676-701-01 |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204384-001 | SIRTURO | BEDAQUILINE FUMARATE | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | |
| N204384-002 | SIRTURO | BEDAQUILINE FUMARATE | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 |
| N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 |
| N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 |
| N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N204384-001 | ODE-251 | 2026-08-09 |
| N204384-001 | ODE-307 | 2027-05-27 |
| N204384-001 | M-306 | 2027-06-21 |
| N204384-001 | NPP | 2028-07-28 |
| N204384-002 | ODE* | 2026-08-09 |
| N204384-002 | ODE-307 | 2027-05-27 |
| N204384-002 | M-306 | 2027-06-21 |
| N204384-002 | NPP | 2028-07-28 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N204384-002 | SIRTURO | EQ 20MG BASE | TABLET / ORAL | RLD | 2020-05-27 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N204384-001 | SIRTURO | EQ 100MG BASE | TABLET / ORAL | RLD, RS | 2012-12-28 | bb7c543d1eb4… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204384-001 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2013-01-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204384-001 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2014-03-14 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204384-002 | 7498343 | 2026-12-01 | U-1321 | Drug substance, Drug product | 2020-06-24 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204384-002 | 8546428 | 2029-03-19 | U-1321 | Drug substance, Drug product | 2020-06-24 | 5bbf6a4d5a75… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | ODE-251 | 2026-08-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | ODE-307 | 2027-05-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | M-306 | 2027-06-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-001 | NPP | 2028-07-28 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | ODE* | 2026-08-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | ODE-307 | 2027-05-27 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | M-306 | 2027-06-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N204384-002 | NPP | 2028-07-28 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-001 | ODE-251 | 2026-08-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-001 | ODE-307 | 2027-05-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-001 | M-306 | 2027-06-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-002 | ODE* | 2026-08-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-002 | ODE-307 | 2027-05-27 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N204384-002 | M-306 | 2027-06-21 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-001 | ODE-251 | 2026-08-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-001 | ODE-307 | 2027-05-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-001 | M-306 | 2027-06-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-002 | ODE* | 2026-08-09 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-002 | ODE-307 | 2027-05-27 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N204384-002 | M-306 | 2027-06-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-001 | ODE-251 | 2026-08-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-001 | ODE-307 | 2027-05-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-001 | M-306 | 2027-06-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-002 | ODE* | 2026-08-09 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-002 | ODE-307 | 2027-05-27 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204384-002 | M-306 | 2027-06-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-001 | ODE-251 | 2026-08-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-001 | ODE-307 | 2027-05-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-001 | M-306 | 2027-06-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-002 | ODE* | 2026-08-09 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-002 | ODE-307 | 2027-05-27 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N204384-002 | M-306 | 2027-06-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-001 | ODE-251 | 2026-08-09 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-001 | ODE-307 | 2027-05-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-001 | M-306 | 2027-06-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-002 | ODE-307 | 2027-05-27 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204384-002 | M-306 | 2027-06-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-001 | ODE-251 | 2026-08-09 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-001 | ODE-307 | 2027-05-27 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204384-001 | M-306 | 2027-06-21 | b8a1b40f171c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SIRTURO | BEDAQUILINE FUMARATE | Janssen Products, LP | 1534c9ae-4948-4cf4-9f66-222a99db6d0e | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | 59676-701-01 59676070101 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.