FDA.reportPublic FDA data

Aspirin Regimen

Product NDC
70000-0603
11-digit product format
700000603
Labeler code
70000
Product ID
70000-0603_1921a0c0-7939-4eb1-b0b5-80fe9c67e47b
Type
HUMAN OTC DRUG
Nonproprietary name
Aspirin
Dosage form
TABLET, DELAYED RELEASE
Route
ORAL
Labeler
Cardinal Health 110, LLC. DBA Leader
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-05
Substance
ASPIRIN
Active strength
81 mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [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 Regimen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN81 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E
Rxcui308416

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0603-1Aspirin Regimen1 in 1 CARTONTABLET, DELAYED RELEASE18
70000-0603-1Aspirin Regimen32 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE328
70000-0603-2Aspirin Regimen1 in 1 CARTONTABLET, DELAYED RELEASE18
70000-0603-2Aspirin Regimen120 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE1208
70000-0603-3Aspirin Regimen300 in 1 BOTTLE, PLASTICTABLET, DELAYED RELEASE3008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0603-1EA - Each70000-060348446eaa-a5fd-4df6-afbc-ec740fe1e54e12024-03-12
70000-0603-2EA - Each70000-060351bc29d9-aa6d-42f9-a408-fe94e122427912022-11-07
70000-0603-3EA - Each70000-0603c0a71aba-7333-4a4b-9ab4-937ca5adc87512023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0603ASPIRIN REGIMEN (ASPIRIN) TABLET, DELAYED RELEASE [CARDINAL HEALTH 110, LLC. DBA LEADER]7Current NDC, Legacy NDC, 5 package rows20250328_ef2d75ee-9ed7-4b53-adbc-2ec40364da63.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308416aspirin 81 MG Delayed Release Oral TabletPSNef2d75ee-9ed7-4b53-adbc-2ec40364da638
308416aspirin 81 MG Delayed Release Oral TabletSCDef2d75ee-9ed7-4b53-adbc-2ec40364da638
308416ASA 81 MG Delayed Release Oral TabletSYef2d75ee-9ed7-4b53-adbc-2ec40364da638
308416aspirin 81 MG Enteric Coated Oral TabletSYef2d75ee-9ed7-4b53-adbc-2ec40364da638

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0603-1700000603011 BOTTLE, PLASTIC in 1 CARTON (70000-0603-1) / 32 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2022-05-050000-00-00NoNoCurrent
70000-0603-2700000603021 BOTTLE, PLASTIC in 1 CARTON (70000-0603-2) / 120 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC2022-05-050000-00-00NoNoCurrent
70000-0603-370000060303300 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70000-0603-3) 2022-05-050000-00-00NoNoCurrent