Budesonide and Formoterol Fumarate Dihydrate
- Product NDC
- 70518-3107
- 11-digit product format
- 705183107
- Labeler code
- 70518
- Product ID
- 70518-3107_e3aee691-e4cc-a959-e053-2a95a90ae51b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Budesonide and Formoterol Fumarate Dihydrate
- Dosage form
- AEROSOL
- Route
- RESPIRATORY (INHALATION)
- Labeler
- REMEDYREPACK INC.
- Application
- NDA021929
- Marketing category
- NDA AUTHORIZED GENERIC
- Marketing start
- 2021-05-27
- Marketing end
- 0000-00-00
- Substance
- BUDESONIDE; FORMOTEROL FUMARATE
- Active strength
- 160 ug/1; ug/1
- Pharmacologic classes
- Adrenergic beta2-Agonists [MoA], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], beta2-Adrenergic Agonist [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 product | product | 70518-3107 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 70518-3107 | 70518-3107-0 | 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 | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded product | product | d630ba8d3edf… | 732f749b63fb… | |
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 70518-3107-0 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded product | product | f5e01cc5f278… | a2eaf40c39c3… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 70518-3107-0 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded product | product | 2ef7874e63bc… | 57b86245f4fa… | |
| 2025-04-01 02:39 UTC · source 2025-03-31 | excluded package | package | 70518-3107-0 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded product | product | a1b67e2a42f9… | c4cf2c586c0d… | |
| 2025-03-28 20:22 UTC · source 2025-03-28 | excluded package | package | 70518-3107-0 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded product | product | cfe11265f3b6… | 090c488252e2… | |
| 2025-03-22 03:12 UTC · source 2025-03-21 | excluded package | package | 70518-3107-0 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded product | product | cdf11ea48f46… | ba0047e9e063… | |
| 2025-03-10 12:48 UTC · source 2025-03-10 | excluded package | package | 70518-3107-0 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 70518-3107-0 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 70518-3107-0 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded product | product | 0efc9e666f02… | f202fb6c5f17… | |
| 2025-01-11 03:41 UTC · source 2025-01-10 | excluded package | package | 70518-3107-0 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded product | product | ad56d346431e… | cc804d4bbf1e… | |
| 2024-11-09 02:27 UTC · source 2024-11-08 | excluded package | package | 70518-3107-0 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 70518-3107-0 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded product | product | 557ba5c1ecfa… | 9c80585c8c6e… | |
| 2024-07-10 04:00 UTC · source 2024-07-09 | excluded package | package | 70518-3107-0 | 557ba5c1ecfa… | 9c80585c8c6e… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021929-001 | SYMBICORT | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 |
| N021929-002 | SYMBICORT | BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N021929-001 | AB |
| N021929-002 | AB |
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 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | RLD, RS | 2006-07-21 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021929-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N021929-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021929-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021929-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N021929-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N021929-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021929-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021929-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021929-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021929-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021929-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021929-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N021929-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N021929-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021929-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021929-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021929-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021929-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021929-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021929-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N021929-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | N021929-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021929-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021929-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N021929-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | N021929-002 | AB | 1 | 5d02ea3f76ae… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021929-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021929-002 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N021929-001 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N021929-002 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N021929-001 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N021929-002 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021929-001 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021929-002 | AB | 1 | a72a2bbeb626… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8875699*PED | 2025-05-10 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 7587988 | 2026-04-10 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 7587988*PED | 2026-10-10 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8387615 | 2027-03-26 | Drug product | 2013-04-04 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8387615*PED | 2027-09-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8528545 | 2028-10-16 | Drug product | 2013-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8616196 | 2029-04-07 | Drug product | 2014-01-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8528545*PED | 2029-04-16 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-001 | 8616196*PED | 2029-10-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8875699*PED | 2025-05-10 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 7587988 | 2026-04-10 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 7587988*PED | 2026-10-10 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8387615 | 2027-03-26 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8387615*PED | 2027-09-26 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8528545 | 2028-10-16 | Drug product | 2013-10-09 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8616196 | 2029-04-07 | Drug product | 2014-01-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8528545*PED | 2029-04-16 | Pediatric extension | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021929-002 | 8616196*PED | 2029-10-07 | Pediatric extension | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8875699*PED | 2025-05-10 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 7587988 | 2026-04-10 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 7587988*PED | 2026-10-10 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8387615 | 2027-03-26 | Drug product | 2013-04-04 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8387615*PED | 2027-09-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8528545 | 2028-10-16 | Drug product | 2013-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8616196 | 2029-04-07 | Drug product | 2014-01-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8528545*PED | 2029-04-16 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-001 | 8616196*PED | 2029-10-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8875699*PED | 2025-05-10 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 7587988 | 2026-04-10 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 7587988*PED | 2026-10-10 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8387615 | 2027-03-26 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8387615*PED | 2027-09-26 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8528545 | 2028-10-16 | Drug product | 2013-10-09 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8616196 | 2029-04-07 | Drug product | 2014-01-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8528545*PED | 2029-04-16 | Pediatric extension | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021929-002 | 8616196*PED | 2029-10-07 | Pediatric extension | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-001 | 8875699 | 2024-11-10 | Drug product | 2014-12-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-001 | 8875699*PED | 2025-05-10 | Pediatric extension | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-001 | 7587988 | 2026-04-10 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021929-001 | 7587988*PED | 2026-10-10 | Pediatric extension | 03ed91905a0d… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021929-001 | NPP | 2020-01-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-001 | PED | 2020-07-27 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-001 | M-210 | 2020-09-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-001 | M-214 | 2020-12-20 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-002 | M-210 | 2020-09-11 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021929-002 | M-214 | 2020-12-20 | 74a2ff9319b5… |
| 2020-12-22 03:56 UTC | 2020-12 | N021929-001 | NPP | 2020-01-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021929-001 | PED | 2020-07-27 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021929-001 | M-210 | 2020-09-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021929-001 | M-214 | 2020-12-20 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021929-002 | M-210 | 2020-09-11 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021929-002 | M-214 | 2020-12-20 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021929-001 | NPP | 2020-01-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021929-001 | PED | 2020-07-27 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021929-001 | M-210 | 2020-09-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021929-001 | M-214 | 2020-12-20 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021929-002 | M-210 | 2020-09-11 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021929-002 | M-214 | 2020-12-20 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021929-001 | NPP | 2020-01-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021929-001 | PED | 2020-07-27 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021929-001 | M-210 | 2020-09-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021929-001 | M-214 | 2020-12-20 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021929-002 | M-210 | 2020-09-11 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021929-002 | M-214 | 2020-12-20 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021929-001 | NPP | 2020-01-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021929-001 | PED | 2020-07-27 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021929-001 | M-210 | 2020-09-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021929-001 | M-214 | 2020-12-20 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021929-002 | M-210 | 2020-09-11 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021929-002 | M-214 | 2020-12-20 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021929-001 | NPP | 2020-01-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021929-001 | PED | 2020-07-27 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021929-001 | M-210 | 2020-09-11 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021929-001 | M-214 | 2020-12-20 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021929-002 | M-210 | 2020-09-11 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021929-002 | M-214 | 2020-12-20 | ea99ee380514… |
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 |
|---|---|---|---|---|---|---|
| Budesonide and Formoterol Fumarate Dihydrate | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | Sportpharm LLC | d6cc66c9-6f97-4ea8-a787-30a048004c77 | 2026-04-24 | Warnings, Adverse reactions | 021929 NDA021929 |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | Sportpharm LLC | a645756c-c692-4bc6-a858-7e7e249561bd | 2026-03-12 | Warnings, Adverse reactions | 021929 NDA021929 |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | A-S Medication Solutions | 6b78d08a-e098-4188-8f7f-94fbd5f396ef | 2024-10-22 | Warnings, Adverse reactions | 021929 NDA021929 |
| Budesonide and Formoterol Fumarate Dihydrate | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | A-S Medication Solutions | b974bab9-c6d2-41ad-b930-28f2904c5f9d | 2024-10-22 | Warnings, Adverse reactions | 021929 NDA021929 |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | A-S Medication Solutions | 805764a1-65e1-4117-ac4a-7a54c3986cfe | 2024-06-28 | Warnings, Adverse reactions | 021929 NDA021929 |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | A-S Medication Solutions | 5feb8f35-b237-477a-9836-2a6db2ed6fa7 | 2024-04-15 | Warnings, Adverse reactions | 021929 NDA021929 |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | A-S Medication Solutions | 52f45e18-463e-4ce3-8ccd-c0260473e6b5 | 2024-04-15 | Warnings, Adverse reactions | 021929 NDA021929 |
| Budesonide and Formoterol Fumarate Dihydrate | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | A-S Medication Solutions | 0ce4cd21-ac96-4b39-9e1c-49f86c87fa1a | 2023-02-06 | Warnings, Adverse reactions | 021929 NDA021929 |
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | AstraZeneca Pharmaceuticals LP | fafa4cf1-99c2-43d5-73ad-51f256de3be0 | 2019-07-24 | Warnings, Adverse reactions | 021929 NDA021929 |
| Budesonide and Formoterol Fumarate Dihydrate | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | AstraZeneca Pharmaceuticals LP | 1d266fe8-52e3-4f85-a037-c5c1afa15e60 | 2019-07-24 | Warnings, Adverse reactions | 021929 NDA021929 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 70518-3107-0 | 70518310700 | 1 POUCH in 1 CARTON (70518-3107-0) > 1 CANISTER in 1 POUCH > 120 AEROSOL in 1 CANISTER | 1 pouch | 2021-05-27 | 0000-00-00 | No | No | Current |