Aspirin and Dipyridamole Extended Release

Product NDC
47335-927
11-digit product format
473350927
Labeler code
47335
Product ID
47335-927_5a1d740e-6d21-4756-b521-365b6cfd6cf6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aspirin and Dipyridamole Extended Release
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA208572
Marketing category
ANDA
Marketing start
2018-12-01
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
2020-12-31
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.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct47335-927IInactivated by FDA2026-09-14
excluded packagepackage47335-92747335-927-83IInactivated by FDA2026-09-14
excluded packagepackage47335-92747335-927-86IInactivated by FDA2026-09-14

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.

Historic NDC status page 1 of 1 · 57 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47335-927-83d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage47335-927-86d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47335-927-83f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage47335-927-86f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47335-927-832ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage47335-927-862ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47335-927-83a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage47335-927-86a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47335-927-83cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage47335-927-86cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47335-927-83cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage47335-927-86cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47335-927-83302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage47335-927-86302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47335-927-83ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage47335-927-86ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47335-927-830efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage47335-927-860efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47335-927-83ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage47335-927-86ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage47335-927-83367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage47335-927-86367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage47335-927-83557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage47335-927-86557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage47335-927-838af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage47335-927-868af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage47335-927-83834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage47335-927-86834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage47335-927-831332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage47335-927-861332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage47335-927-83fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage47335-927-86fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage47335-927-8386f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage47335-927-8686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage47335-927-83bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage47335-927-86bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage47335-927-838dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage47335-927-868dfbde2a14a4…c9ff85d89658…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208572-001ASPIRIN AND DIPYRIDAMOLEASPIRIN; DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-2184e616aacf4f…
2026-08-18 06:07:402026-07A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-213f01610625f2…
2019-09-15 20:21 UTC2019-09A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2018-08-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208572-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORAL2018-08-21f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A208572-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208572-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A208572-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208572-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208572-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208572-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208572-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208572-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-927-83Aspirin and Dipyridamole Extended Release30 in 1 BOTTLECAPSULE304
47335-927-86Aspirin and Dipyridamole Extended Release60 in 1 BOTTLECAPSULE604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-927ASPIRIN AND DIPYRIDAMOLE EXTENDED RELEASE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]4Legacy NDC, 2 package rows20190122_e85a2ba8-9d8a-4921-8a6d-5c04a0604926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSNe85a2ba8-9d8a-4921-8a6d-5c04a06049264
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCDe85a2ba8-9d8a-4921-8a6d-5c04a06049264
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSYe85a2ba8-9d8a-4921-8a6d-5c04a06049264
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSYe85a2ba8-9d8a-4921-8a6d-5c04a06049264

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
47335-927-834733509278330 in 1 BOTTLEHistorical
47335-927-864733509278660 in 1 BOTTLEHistorical