69168-457 NDC - ASPIRIN 81MG

Drug Information

  • Product NDC: 69168-457
  • Proprietary Name: Aspirin 81mg
  • Non Proprietary Name: Aspirin 81mg
  • Active Ingredient(s): 81 mg/1 ASPIRIN
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Allegiant Health
Product Type: HUMAN OTC DRUG
FDA Application Number: M013
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:5/9/2024

Package Information

No. Package Code Package Description Billing Unit
169168-457-98200 TABLET, FILM COATED in 1 BOTTLE (69168-457-98)

NDC Record

Field Name Field Value Definition
PRODUCT NDC69168-457The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PRODUCT TYPE NAMEHUMAN OTC DRUGThe translation of the dosage form Code submitted by the firm.
PROPRIETARY NAMEAspirin 81mgThe translation of the route code submitted by the firm, indicating route of administration.
PROPRIETARY NAME SUFFIXDye-FreeThis is the date that the labeler indicates was the start of its marketing of the drug product.
NON PROPRIETARY NAMEAspirin 81mgThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/9/2024This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUG 
APPLICATION NUMBERM013This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEAllegiant Health 
SUBSTANCE NAMEASPIRINAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH81 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESAnti-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] 

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This page was last updated on: 12/6/2025