Home NDC 0115-1070 Dipyridamole
Product NDC 0115-1070
11-digit product format 001151070
Labeler code 0115
Product ID 0115-1070_02250a0f-40e1-4f73-8ead-1be26f78edc8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name DIPYRIDAMOLE
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals of New York LLC
Application ANDA040782
Marketing category ANDA
Marketing start 2021-08-30
Substance DIPYRIDAMOLE
Active strength 25 mg/1
Pharmacologic classes Decreased Platelet Aggregation [PE], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A040782-001 DIPYRIDAMOLE DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 A040782-002 DIPYRIDAMOLE DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 A040782-003 DIPYRIDAMOLE DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18
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 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040782-002 DIPYRIDAMOLE 50MG TABLET / ORAL AB 2007-07-18 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040782-003 DIPYRIDAMOLE 75MG TABLET / ORAL AB RS 2007-07-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040782-001 DIPYRIDAMOLE 25MG TABLET / ORAL AB 2007-07-18 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 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPYRIDAMOLE 25 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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0115-1070-01 Dipyridamole 100 in 1 BOTTLE TABLET 100 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DIPYRIDAMOLE ACTIVE INGREDIENT 64ALC7F90C DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 DIPYRIDAMOLE ACTIVE MOIETY 64ALC7F90C DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 TALC INACTIVE INGREDIENT 7SEV7J4R1U DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIPYRIDAMOLE TABLET [GLOBAL PHARMACEUTICALS, DIVISION OF IMPAX LABORATORIES INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0115-1070 DIPYRIDAMOLE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] 7 Current NDC, Legacy NDC, 1 package rows 20230418_a18b2af5-7c4a-4b7f-92c7-8a76e34da373.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 Units Marketing start Marketing end Sample Exclude flag Status 0115-1070-01 00115107001 100 TABLET in 1 BOTTLE (0115-1070-01) 100 tablet 2021-08-30 0000-00-00 No No Current