Ortikos
- Product NDC
- 55566-1002
- Requested package NDC
- 55566-1002-1
- 11-digit product format
- 555661002
- Labeler code
- 55566
- Product ID
- 55566-1002_69c1e200-f5ae-429f-b890-b2418700a7e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Ferring Pharmaceuticals Inc.
- Application
- NDA211929
- Marketing category
- NDA
- Marketing start
- 2020-07-20
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE
- Active strength
- 6 mg/1
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 55566-1002 | 55566-1002-1 | D | Discontinued by firm | 2026-08-03 |
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.
| Captured / source date | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211929-001 | ORTIKOS | BUDESONIDE | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | |
| N211929-002 | ORTIKOS | BUDESONIDE | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | |
| N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 |
| N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | |
| N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211929-001 | ORTIKOS | 6MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211929-002 | ORTIKOS | 9MG | CAPSULE, DELAYED RELEASE / ORAL | RLD | 2019-06-13 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211929-001 | ORTIKOS | 6MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-06-13 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211929-002 | ORTIKOS | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2019-06-13 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211929-001 | ORTIKOS | 6MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-06-13 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211929-002 | ORTIKOS | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2019-06-13 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211929-001 | ORTIKOS | 6MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-06-13 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211929-002 | ORTIKOS | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2019-06-13 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N211929-001 | ORTIKOS | 6MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-06-13 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N211929-002 | ORTIKOS | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2019-06-13 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N211929-001 | ORTIKOS | 6MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-06-13 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N211929-002 | ORTIKOS | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2019-06-13 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N211929-001 | ORTIKOS | 6MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 2019-06-13 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N211929-002 | ORTIKOS | 9MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2019-06-13 | 782e0a99824c… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N211929-001 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211929-001 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N211929-002 | 10172802 | 2036-09-09 | U-2554 | 2019-06-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211929-002 | 9707182 | 2036-09-09 | U-2554 | Drug product | 2019-06-28 | d06236e962d9… |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 55566-1002-1 | EA - Each | 55566-1002 | e226b2ed-0e56-499e-86a1-32954c954ac5 | 1 | 2020-08-06 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 55566-1002-1 | 55566100201 | 30 CAPSULE in 1 BOTTLE (55566-1002-1) | 30 capsule | 2020-07-20 | 0000-00-00 | No | No | Current |