DIPYRIDAMOLE

Product NDC
51662-1447
11-digit product format
516621447
Labeler code
51662
Product ID
51662-1447_2b3982ff-1c0e-7dfa-e063-6394a90af38f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIPYRIDAMOLE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA074521
Marketing category
ANDA
Marketing start
2020-01-10
Substance
DIPYRIDAMOLE
Active strength
5 mg/mL
Pharmacologic classes
Decreased Platelet Aggregation [PE], 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 42.

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
A074521-001DIPYRIDAMOLEDIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074521-001AP

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-183f01610625f2…
2019-09-15 20:21 UTC2019-09A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074521-001DIPYRIDAMOLE5MG/MLINJECTABLE / INJECTIONAP1996-10-18e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A074521-001AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074521-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074521-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074521-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074521-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074521-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074521-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074521-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074521-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074521-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074521-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074521-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074521-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074521-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074521-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074521-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074521-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074521-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074521-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074521-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074521-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074521-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A074521-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074521-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074521-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074521-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A074521-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074521-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074521-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074521-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074521-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074521-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074521-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074521-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074521-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074521-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074521-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074521-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074521-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A074521-001AP1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
DIPYRIDAMOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPYRIDAMOLE5 mg/mL

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
309953Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9bd34108-9d98-c4ca-e053-2995a90a2bc8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1447-1DIPYRIDAMOLE10 mL in 1 VIALINJECTION103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1447DIPYRIDAMOLE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST]3Current NDC, Legacy NDC, 1 package rows20250110_9bd34108-9d98-c4ca-e053-2995a90a2bc8.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DipyridamoleDIPYRIDAMOLEHikma Pharmaceuticals USA Inc.6093dcd9-82d2-414f-8507-eda22c14f6262026-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074521
application number: ANDA074521
DipyridamoleDIPYRIDAMOLEHenry Schein, Inc.1a2c0a9a-c637-4485-ad4b-0b6d0b05fa202025-10-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074521
application number: ANDA074521
DIPYRIDAMOLEDIPYRIDAMOLEHF Acquisition Co LLC, DBA HealthFirst9bd34108-9d98-c4ca-e053-2995a90a2bc82025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074521
application number: ANDA074521
ndc (product): 51662-1447

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309953dipyridamole 50 MG in 10 ML InjectionPSN9bd34108-9d98-c4ca-e053-2995a90a2bc83
30995310 ML dipyridamole 5 MG/ML InjectionSCD9bd34108-9d98-c4ca-e053-2995a90a2bc83
309953dipyridamole 50 MG per 10 ML InjectionSY9bd34108-9d98-c4ca-e053-2995a90a2bc83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1447-15166214470110 mL in 1 VIAL (51662-1447-1) 10 ml2020-01-100000-00-00NoNoCurrent