Home NDC 0404-9852 Dipyridamole
Product NDC 0404-9852
11-digit product format 004049852
Labeler code 0404
Product ID 0404-9852_aa6a1a43-815a-4c9a-9720-d3c04bad6e4d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dipyridamole
Dosage form INJECTION
Route INTRAVENOUS
Labeler Henry Schein, Inc.
Application ANDA074521
Marketing category ANDA
Marketing start 2022-01-10
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-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 2026-12-31 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 0404-9852-10 Dipyridamole 10 mL in 1 VIAL, SINGLE-DOSE INJECTION 10 5 0404-9852-10 Dipyridamole 1 in 1 BAG INJECTION 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0404-9852 DIPYRIDAMOLE INJECTION [HENRY SCHEIN, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20241016_1a2c0a9a-c637-4485-ad4b-0b6d0b05fa20.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 Marketing start Marketing end Sample Exclude flag Status 0404-9852-10 00404985210 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9852-10) / 10 mL in 1 VIAL, SINGLE-DOSE 2022-01-10 0000-00-00 No No Current