FDA.reportPublic FDA data

Aspirin and Extended-Release Dipyridamole

Product NDC
42291-116
11-digit product format
422910116
Labeler code
42291
Product ID
42291-116_485b7e08-a8d8-f491-e063-6294a90aa415
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aspirin and Extended-Release Dipyridamole
Dosage form
CAPSULE
Route
ORAL
Labeler
AvKARE
Application
ANDA206392
Marketing category
ANDA
Marketing start
2017-04-27
Substance
ASPIRIN; DIPYRIDAMOLE
Active strength
25; 200 mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Platelet Aggregation Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aspirin and Extended-Release Dipyridamole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN25 mg/1
DIPYRIDAMOLE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, 64ALC7F90C
Rxcui259081

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
3285f096-1048-1647-9b36-a2e0f5b56c6cProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
9ab2f788-fb50-9b8e-e14c-49841b1b5968Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42291-116-60Aspirin and Extended-Release Dipyridamole60 in 1 BOTTLECAPSULE607

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-116-60EA - Each42291-116b2468af9-180b-4a30-9902-a4624c4f380e12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-116ASPIRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULE [AVKARE]6Current NDC, Legacy NDC, 1 package rows20240110_c9a73ec9-e468-46a5-b2c1-99f1f1536585.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSNc9a73ec9-e468-46a5-b2c1-99f1f15365857
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCDc9a73ec9-e468-46a5-b2c1-99f1f15365857
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSYc9a73ec9-e468-46a5-b2c1-99f1f15365857
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSYc9a73ec9-e468-46a5-b2c1-99f1f15365857

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-116-604229101166060 CAPSULE in 1 BOTTLE (42291-116-60) 60 capsule2017-04-270000-00-00NoNoCurrent