Aggrenox
- Product NDC
- 0597-0001
- 11-digit product format
- 005970001
- Labeler code
- 0597
- Product ID
- 0597-0001_afbcb310-8722-47df-acac-c5fcb2c4bb2f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- aspirin and dipyridamole
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Boehringer Ingelheim Pharmaceuticals Inc.
- Application
- NDA020884
- Marketing category
- NDA
- Marketing start
- 1999-12-19
- Marketing end
- 0000-00-00
- Substance
- ASPIRIN; DIPYRIDAMOLE
- Active strength
- 25 mg/1; mg/1
- Pharmacologic classes
- Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded product | product | 0597-0001 | D | Discontinued by firm | 2026-08-03 | ||
| excluded package | package | 0597-0001 | 0597-0001-11 | D | Discontinued by firm | 2026-08-03 | |
| excluded package | package | 0597-0001 | 0597-0001-60 | D | Discontinued by firm | 2026-08-03 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020884-001 | AGGRENOX | ASPIRIN; DIPYRIDAMOLE | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 |
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 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020884-001 | AGGRENOX | 25MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD | 1999-11-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020884-001 | AGGRENOX | 25MG;200MG | CAPSULE, EXTENDED RELEASE / ORAL | AB | RLD, RS | 1999-11-22 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020884-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020884-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020884-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020884-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020884-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020884-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020884-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020884-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020884-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020884-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020884-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020884-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020884-001 | AB | 1 | ea99ee380514… |
| 2022-10-28 04:53 UTC | 2022-10 | N020884-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020884-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020884-001 | AB | 1 | cb3db0bc1861… |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d7724692-1155-4cc8-a415-22f5fc4aec35 | Product name | 6 | 20220216 |
| bde672ba-4805-28d0-1986-73543d41b412 | Product name | 2 | 20210201 |
| f52be47f-7aa7-46c0-b1fa-50c18dd50206 | Product name | 1 | 20201029 |
| f212291f-05fe-9603-fc7e-bd73e38ce1e6 | Product name | 2 | 20161129 |
| ade821ba-260a-47e2-bd89-743e27ac9906 | Product name | 1 | 20161121 |
| 182f9ab4-4ab5-c449-200f-87ce2ce8e550 | Product name | 2 | 20151105 |
| 9425d234-4ae1-4b53-adc6-8cc7af6dd657 | Product name | 1 | 20150929 |
| 2a21311a-89e2-0e83-2ebd-117f9798b2b2 | Product name | 1 | 20140508 |
| 3285f096-1048-1647-9b36-a2e0f5b56c6c | Product name | 1 | 20140508 |
| 9007e8a7-ff50-f9b9-7945-f2a1deadd94e | Product name | 1 | 20140508 |
| 96c2be53-8e44-452d-56a2-d255b2f1af2d | Product name | 1 | 20140508 |
| 9ab2f788-fb50-9b8e-e14c-49841b1b5968 | Product name | 1 | 20140508 |
| bf8bd5f7-495f-4022-2780-7ded7ea7ea44 | Product name | 1 | 20140508 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0597-0001-60 | EA - Each | 0597-0001 | 29373277-52cb-4af8-b604-4676b6a47cc9 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1362082 | Aggrenox 25 MG / 200 MG 12HR Extended Release Oral Capsule | PSN | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 259081 | aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral Capsule | PSN | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 1362082 | 12 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox] | SBD | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 259081 | 12 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule | SCD | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 259081 | 12 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule | SY | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 1362082 | 12 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox] | SY | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 1362082 | Aggrenox 25/200 (aspirin 25 MG / dipyridamole 200 MG) 12HR Extended Release Oral Capsule | SY | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 1362082 | Aggrenox 25/200 12HR Extended Release Oral Capsule | SY | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 259081 | aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral Capsule | SY | f07c8535-f9fb-4697-9b63-1ab22210efc9 | 3 |
| 1362082 | Aggrenox 25 MG / 200 MG 12HR Extended Release Oral Capsule | PSN | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 259081 | aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral Capsule | PSN | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 1362082 | 12 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox] | SBD | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 259081 | 12 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral Capsule | SCD | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 259081 | 12 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule | SY | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 1362082 | 12 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral Capsule [Aggrenox] | SY | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 1362082 | Aggrenox 25/200 (aspirin 25 MG / dipyridamole 200 MG) 12HR Extended Release Oral Capsule | SY | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 1362082 | Aggrenox 25/200 12HR Extended Release Oral Capsule | SY | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
| 259081 | aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral Capsule | SY | e729d829-4bd0-4074-85ea-e0f9f5d7cdb5 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0597-0001-60 | 00597000160 | 1 BOTTLE in 1 CARTON (0597-0001-60) > 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 1 bottle | 1999-12-19 | 0000-00-00 | No | No | Current |