Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg

Product NDC
49884-007
11-digit product format
498840007
Labeler code
49884
Product ID
49884-007_1f495553-0af4-49ab-89af-7cf5a5094d46
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aspirin and Extended - Release Dipyridamole
Dosage form
CAPSULE
Route
ORAL
Labeler
Endo USA, Inc.
Application
ANDA207944
Marketing category
ANDA
Marketing start
2017-01-30
Substance
ASPIRIN; DIPYRIDAMOLE
Active strength
25; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A207944-001ASPIRIN AND DIPYRIDAMOLEASPIRIN; DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A207944-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-183f01610625f2…
2019-09-15 20:21 UTC2019-09A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207944-001ASPIRIN AND DIPYRIDAMOLE25MG;200MGCAPSULE, EXTENDED RELEASE / ORALAB2017-01-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A207944-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207944-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A207944-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207944-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207944-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207944-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207944-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207944-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207944-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207944-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207944-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207944-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207944-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207944-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207944-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207944-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207944-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207944-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A207944-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A207944-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A207944-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A207944-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A207944-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A207944-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A207944-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A207944-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A207944-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A207944-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A207944-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A207944-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A207944-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A207944-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A207944-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A207944-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A207944-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A207944-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A207944-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A207944-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A207944-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A207944-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN25 mg/1
DIPYRIDAMOLE200 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
R16CO5Y76EInternal UNII lookup
64ALC7F90CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
259081Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
237a1f63-53ff-47fa-903c-ac6276e594a2Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49884-007-02Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mg60 in 1 BOTTLECAPSULE6019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-007-02EA - Each49884-0072d2b42ac-272f-4d59-aee9-ecf15303a5dc12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49884-007ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE CAPSULES, 25 MG / 200 MG (ASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLE) CAPSULE [ENDO USA, INC.]19Current NDC, Legacy NDC, 1 package rows20250109_237a1f63-53ff-47fa-903c-ac6276e594a2.zip

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.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mgASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLEMajor Pharmaceuticalsa6e652e1-b2e4-47ba-bed2-c5e902f8b8f12025-01-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207944
application number: ANDA207944
Aspirin and Extended - Release Dipyridamole Capsules, 25 mg / 200 mgASPIRIN AND EXTENDED - RELEASE DIPYRIDAMOLEEndo USA, Inc.237a1f63-53ff-47fa-903c-ac6276e594a22021-10-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 207944
application number: ANDA207944
ndc (product): 49884-007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSN237a1f63-53ff-47fa-903c-ac6276e594a219
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCD237a1f63-53ff-47fa-903c-ac6276e594a219
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSY237a1f63-53ff-47fa-903c-ac6276e594a219
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSY237a1f63-53ff-47fa-903c-ac6276e594a219
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSNa6e652e1-b2e4-47ba-bed2-c5e902f8b8f13
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCDa6e652e1-b2e4-47ba-bed2-c5e902f8b8f13
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSYa6e652e1-b2e4-47ba-bed2-c5e902f8b8f13
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSYa6e652e1-b2e4-47ba-bed2-c5e902f8b8f13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-007-024988400070260 CAPSULE in 1 BOTTLE (49884-007-02) 60 capsule2017-01-300000-00-00NoNoCurrent