Lannett Company, Inc. | SGS Life Science Services | Eurofins Lancaster Laboratories, Inc | NEOLPHARMA, INC. | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Siegfried PharmaChemikalien Minden Gmbh | Aesica Pharmaceuticals GmbH | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Aspen Oss B.V. | Mipharm SPA blanket no changes certification of product listing
- Manufacturer
- Lannett Company, Inc. | SGS Life Science Services | Eurofins Lancaster Laboratories, Inc | NEOLPHARMA, INC. | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Schuetzenstrasse) | Siegfried PharmaChemikalien Minden Gmbh | Aesica Pharmaceuticals GmbH | Vetter Pharma Fertigung GmbH & Co. KG (Langenargen Eisenbahnstrasse) | Aspen Oss B.V. | Mipharm SPA
- Effective date
- 2017-10-11
- Label type
- BLANKET NO CHANGES CERTIFICATION OF PRODUCT LISTING
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-06-01 02:48:37
Label at a glance#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 52244-010-02 | EA - Each | 52244-010 | 54cae4fb-e0d7-43c6-8fb9-e62fa5201fda | 1 | 2012-07-24 |
| 52244-010-06 | EA - Each | 52244-010 | e446ade9-d2cd-4848-a46a-6f2d6c5b2aa8 | 1 | 2012-07-24 |
| 52244-020-02 | EA - Each | 52244-020 | 8d9860df-4a20-4b03-8217-c23db07e7b89 | 1 | 2012-07-24 |
| 52244-020-06 | EA - Each | 52244-020 | 9d7d0183-2bb6-4656-9e30-b7ea2568ca84 | 1 | 2012-07-24 |
| 52244-040-02 | EA - Each | 52244-040 | 18882348-6992-4ad5-890c-7bac309f72a8 | 1 | 2012-07-24 |
| 52244-040-06 | EA - Each | 52244-040 | e6aa1ffd-cbaf-4e2c-a0f3-190671784d5a | 1 | 2012-07-24 |
| 52244-100-10 | EA - Each | 52244-100 | f0596013-f229-4b27-affd-bb3bf2ce7270 | 1 | 2015-01-05 |
| 52244-200-10 | EA - Each | 52244-200 | 57466a2d-08ef-4ec8-b204-ecc75513ec1d | 1 | 2015-01-05 |
| 52244-300-10 | EA - Each | 52244-300 | 4b981261-96fe-43b9-9433-67be92b88b23 | 1 | 2015-01-05 |
| 52244-400-10 | EA - Each | 52244-400 | b70cb5c8-c4b4-4983-bad8-dfcf7620192e | 1 | 2015-01-05 |
| 52244-030-60 | EA - Each | 52244-030 | 38065b96-98f5-4cc2-af4f-6da6b4eb2fdc | 1 | 2013-06-04 |
NDC Codes#
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | ea99ee380514… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A081034-001 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | ea99ee380514… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087942-001 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | cb3db0bc1861… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087943-001 | THEO-24 | THEOPHYLLINE | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | |
| A087943-002 | THEO-24 | THEOPHYLLINE | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | ||
| A087943-003 | THEO-24 | THEOPHYLLINE | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | ||
| A087943-004 | THEO-24 | THEOPHYLLINE | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 |
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 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087943-001 | THEO-24 | 200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1983-08-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087943-002 | THEO-24 | 100MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087943-003 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087943-004 | THEO-24 | 400MG | CAPSULE, EXTENDED RELEASE / ORAL | RS | 1992-02-28 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | ea99ee380514… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087944-001 | THEO-24 | 300MG | CAPSULE, EXTENDED RELEASE / ORAL | 1983-08-22 | cb3db0bc1861… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020649-001 | EDEX | ALPROSTADIL | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | ||
| N020649-002 | EDEX | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 |
| N020649-003 | EDEX | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 |
| N020649-004 | EDEX | ALPROSTADIL | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 |
| N020649-005 | EDEX | ALPROSTADIL | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | |
| N020649-006 | EDEX | ALPROSTADIL | 0.02MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | |
| N020649-007 | EDEX | ALPROSTADIL | 0.04MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020649-002 | AP |
| N020649-003 | AP |
| N020649-004 | AP |
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 | N020649-001 | EDEX | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N020649-002 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020649-003 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020649-004 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020649-005 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020649-006 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N020649-007 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N020649-001 | EDEX | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N020649-002 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020649-003 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020649-004 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020649-005 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020649-006 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020649-007 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-001 | EDEX | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N020649-002 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-003 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-004 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-005 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-006 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-007 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-001 | EDEX | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-002 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-003 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-004 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-005 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-006 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-007 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-001 | EDEX | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N020649-002 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-003 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-004 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-005 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-006 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-007 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-001 | EDEX | 0.005MG/VIAL | INJECTABLE / INJECTION | 1997-06-12 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-002 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-003 | EDEX | 0.02MG/VIAL | INJECTABLE / INJECTION | AP | RLD | 1997-06-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-004 | EDEX | 0.04MG/VIAL | INJECTABLE / INJECTION | AP | RLD, RS | 1997-06-12 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-005 | EDEX | 0.01MG/VIAL | INJECTABLE / INJECTION | RLD, RS | 1998-07-30 | fd3edfee7708… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N020649-002 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020649-003 | AP | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N020649-004 | AP | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | N020649-002 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020649-003 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N020649-004 | AP | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-002 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-003 | AP | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | N020649-004 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-002 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-003 | AP | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020649-004 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-002 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-003 | AP | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | N020649-004 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-002 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-003 | AP | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020649-004 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020649-002 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020649-003 | AP | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020649-004 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020649-002 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020649-003 | AP | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020649-004 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020649-002 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020649-003 | AP | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020649-004 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020649-002 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020649-003 | AP | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020649-004 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020649-002 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020649-003 | AP | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020649-004 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020649-002 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020649-003 | AP | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | N020649-004 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020649-002 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020649-003 | AP | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020649-004 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020649-002 | AP | 1 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Theo-24 | THEOPHYLLINE ANHYDROUS | ENDO USA, Inc. | 7a108fa0-c230-475f-be93-6f864b98a410 | 2024-07-08 | Warnings, Adverse reactions | 52244-400 52244-300 52244-100 52244-200 |
| Edex | ALPROSTADIL | Endo USA, Inc. | e8b8ec8d-1318-43e4-a182-446e9f9579de | 2024-03-27 | Warnings, Adverse reactions | 52244-010 52244-020 52244-040 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.