Home NDC 0641-2569 Dipyridamole
Product NDC 0641-2569
11-digit product format 006412569
Labeler code 0641
Product ID 0641-2569_23eb358a-2250-4a58-a8b7-735beaab1f83
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dipyridamole
Dosage form INJECTION
Route INTRAVENOUS
Labeler Hikma Pharmaceuticals USA Inc.
Application ANDA074521
Marketing category ANDA
Marketing start 1996-10-18
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A074521-001 DIPYRIDAMOLE DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A074521-001 AP
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A074521-001 DIPYRIDAMOLE 5MG/ML INJECTABLE / INJECTION AP 1996-10-18 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Dipyridamole
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPYRIDAMOLE 5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 64ALC7F90C Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 309953 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0641-2569-41 Dipyridamole 10 mL in 1 VIAL INJECTION 10 8 0641-2569-44 Dipyridamole 5 in 1 CARTON INJECTION 5 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0641-2569 DIPYRIDAMOLE INJECTION [HIKMA PHARMACEUTICALS USA INC.] 8 Current NDC, Legacy NDC, 2 package rows 20240410_6093dcd9-82d2-414f-8507-eda22c14f626.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0641-2569-41 00641256941 10 mL in 1 VIAL 10 ml Historical 0641-2569-44 00641256944 5 VIAL in 1 CARTON (0641-2569-44) / 10 mL in 1 VIAL (0641-2569-41) 5 vial 1996-10-18 0000-00-00 No No Current