National Council for Prescription Drug Programs indexing - billing unit
- Manufacturer
- National Council for Prescription Drug Programs
- Effective date
- 2012-07-24
- Label type
- Indexing - Billing Unit
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-05 02:05:06
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0186-0372-20 | GM - Gram | 0186-0372 | 77ea8c50-a43d-453b-beb8-e579af944665 | 1 | 2012-07-24 |
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0186-0372 | 0186-0372-20 |
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 |
|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021929-001 | SYMBICORT | 0.08MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021929-002 | SYMBICORT | 0.16MG/INH;0.0045MG/INH | AEROSOL, METERED / INHALATION | AB | RLD, RS | 2006-07-21 | caaa826d4ba7… |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N021929-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N021929-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N021929-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N021929-002 | AB | 1 | caaa826d4ba7… |
| 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… |
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 |
|---|---|---|---|---|---|---|
| SYMBICORT | BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE | AstraZeneca Pharmaceuticals LP | fafa4cf1-99c2-43d5-73ad-51f256de3be0 | 2019-07-24 | Warnings, Adverse reactions | 0186-0372-20 00186037220 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.