Home NDC 68382-189 Dipyridamole
Product NDC 68382-189
11-digit product format 683820189
Labeler code 68382
Product ID 68382-189_8b638b19-214a-4a58-a336-656d690130e3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Dipyridamole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Zydus Pharmaceuticals USA Inc.
Application ANDA040874
Marketing category ANDA
Marketing start 2008-05-22
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 A040874-001 DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 A040874-002 DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 A040874-003 DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28
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 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040874-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2008-01-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040874-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB 2008-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040874-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2008-01-28 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 126 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 68382-189-01 Dipyridamole 100 in 1 BOTTLE TABLET, FILM COATED 100 10 68382-189-05 Dipyridamole 500 in 1 BOTTLE TABLET, FILM COATED 500 10 68382-189-10 Dipyridamole 1000 in 1 BOTTLE TABLET, FILM COATED 1000 10 68382-189-77 Dipyridamole 10 in 1 BLISTER PACK TABLET, FILM COATED 10 10 68382-189-77 Dipyridamole 10 in 1 CARTON TABLET, FILM COATED 10 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPYRIDAMOLE ACTIVE INGREDIENT 64ALC7F90C DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 DIPYRIDAMOLE ACTIVE MOIETY 64ALC7F90C DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68382-189 DIPYRIDAMOLE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] 10 Current NDC, Legacy NDC, 5 package rows 20230917_004bada0-dbf7-4a94-8792-6833d7eeda2b.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 68382-189-01 68382018901 100 TABLET, FILM COATED in 1 BOTTLE (68382-189-01) 2008-05-22 0000-00-00 No No Current 68382-189-05 68382018905 500 TABLET, FILM COATED in 1 BOTTLE (68382-189-05) 2008-05-22 0000-00-00 No No Current 68382-189-10 68382018910 1000 TABLET, FILM COATED in 1 BOTTLE (68382-189-10) 2008-05-22 0000-00-00 No No Current 68382-189-77 68382018977 10 BLISTER PACK in 1 CARTON (68382-189-77) / 10 TABLET, FILM COATED in 1 BLISTER PACK 10 blister pack 2008-05-22 0000-00-00 No No Current