FDA.reportPublic FDA data

ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE

Product NDC
68462-405
11-digit product format
684620405
Labeler code
68462
Product ID
68462-405_d202f375-08c4-42da-bd96-2b62d7ebe7e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE
Dosage form
CAPSULE
Route
ORAL
Labeler
Glenmark Pharmaceuticals Inc., USA
Application
ANDA210318
Marketing category
ANDA
Marketing start
2019-05-24
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
ASPRIN 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
68462-405-30ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE30 in 1 BOTTLECAPSULE306
68462-405-60ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE60 in 1 BOTTLECAPSULE606

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-405-60EA - Each68462-4059624ecc3-8cf3-4930-bb87-e6aa7e13c5cd12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-405ASPRIN AND EXTENDED-RELEASE DIPYRIDAMOLE CAPSULE [GLENMARK PHARMACEUTICALS INC., USA]5Current NDC, Legacy NDC, 2 package rows20240104_467d6ce3-bc05-4aa1-87cc-3214fd628d39.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsulePSN467d6ce3-bc05-4aa1-87cc-3214fd628d396
25908112 HR aspirin 25 MG / dipyridamole 200 MG Extended Release Oral CapsuleSCD467d6ce3-bc05-4aa1-87cc-3214fd628d396
25908112 HR ASA 25 MG / Dipyridamole 200 MG Extended Release Oral CapsuleSY467d6ce3-bc05-4aa1-87cc-3214fd628d396
259081aspirin 25 MG / dipyridamole 200 MG 12HR Extended Release Oral CapsuleSY467d6ce3-bc05-4aa1-87cc-3214fd628d396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-405-306846204053030 CAPSULE in 1 BOTTLE (68462-405-30) 30 capsule2019-05-240000-00-00NoNoCurrent
68462-405-606846204056060 CAPSULE in 1 BOTTLE (68462-405-60) 60 capsule2019-05-240000-00-00NoNoCurrent