Home NDC 69584-183 Dipyridamole
Product NDC 69584-183
11-digit product format 695840183
Labeler code 69584
Product ID 69584-183_6cf8d202-17fc-4c56-be33-4d74f6591077
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dipyridamole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Oxford Pharmaceuticals, LLC
Application ANDA040542
Marketing category ANDA
Marketing start 2021-04-15
Substance DIPYRIDAMOLE
Active strength 75 mg/1
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 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A040542-001 DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 A040542-002 DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 A040542-003 DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 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 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040542-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2006-04-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040542-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2006-04-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040542-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2006-04-21 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 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 75 mg/1
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 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 197622 Internal RxNorm lookup 309952 Internal RxNorm lookup 309955 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 69584-183-10 Dipyridamole 100 in 1 BOTTLE TABLET, FILM COATED 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69584-183 DIPYRIDAMOLE TABLET, FILM COATED [OXFORD PHARMACEUTICALS, LLC] 1 Current NDC, Legacy NDC, 1 package rows 20210416_f7ffd78a-e93a-40f4-8193-2d6ab4dafd00.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 · 1 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 69584-183-10 69584018310 100 TABLET, FILM COATED in 1 BOTTLE (69584-183-10) 2021-04-15 0000-00-00 No No Current