Dipyridamole

Product NDC
70518-4650
11-digit product format
705184650
Labeler code
70518
Product ID
70518-4650_509b6d30-eda6-417e-e063-6294a90a4a94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dipyridamole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040874
Marketing category
ANDA
Marketing start
2026-04-29
Substance
DIPYRIDAMOLE
Active strength
50 mg/1
Pharmacologic classes
Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040874-001DIPYRIDAMOLEDIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28
A040874-002DIPYRIDAMOLEDIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28
A040874-003DIPYRIDAMOLEDIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040874-001AB
A040874-002AB
A040874-003AB

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 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28caaa826d4ba7…
2026-08-18 06:07:402026-07A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040874-002DIPYRIDAMOLE50MGTABLET / ORALAB2008-01-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040874-003DIPYRIDAMOLE75MGTABLET / ORALAB2008-01-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040874-001DIPYRIDAMOLE25MGTABLET / ORALAB2008-01-281e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040874-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040874-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040874-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040874-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040874-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040874-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040874-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040874-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040874-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040874-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040874-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040874-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040874-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040874-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040874-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040874-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040874-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040874-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040874-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040874-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040874-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040874-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040874-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040874-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040874-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040874-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040874-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040874-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040874-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040874-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040874-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040874-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040874-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040874-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040874-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040874-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040874-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040874-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040874-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040874-001AB11e350fbaab3a…

Additional Listing Data#

Finished product
Yes
Brand name base
Dipyridamole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPYRIDAMOLE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197622Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
226099e2-70bb-4b9b-bb52-c20fbca2aec5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-4650-0Dipyridamole50 in 1 BOXTABLET, FILM COATED501
70518-4650-1Dipyridamole1 in 1 POUCHTABLET, FILM COATED11

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DipyridamoleDIPYRIDAMOLEREMEDYREPACK INC.226099e2-70bb-4b9b-bb52-c20fbca2aec52026-04-29Adverse reactionsExact identifier
application applno (ANDA): 040874
application number: ANDA040874
ndc (product): 70518-4650
DipyridamoleDIPYRIDAMOLEZydus Lifesciences Limited312aadb1-435c-4aa7-8e46-6506cedacaa02024-11-26Exact identifier
application applno (ANDA): 040874
application number: ANDA040874
DipyridamoleDIPYRIDAMOLEZydus Pharmaceuticals USA Inc.004bada0-dbf7-4a94-8792-6833d7eeda2b2023-09-16Adverse reactionsExact identifier
application applno (ANDA): 040874
application number: ANDA040874

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197622dipyridamole 50 MG Oral TabletPSN226099e2-70bb-4b9b-bb52-c20fbca2aec51
197622dipyridamole 50 MG Oral TabletSCD226099e2-70bb-4b9b-bb52-c20fbca2aec51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4650-07051846500050 POUCH in 1 BOX (70518-4650-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4650-1) 50 pouch2026-04-29NoNoCurrent
70518-4650-1705184650011 in 1 POUCHHistorical