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Drug Information

Product NDC: 80425-0139

Proprietary Name: Ketorolac Tromethamine

Non Proprietary Name: Ketorolac Tromethamine

Active Ingredient(s):

Administration Route(s): ORAL


Pharmacy Class(es):
  • Anti-Inflammatory Agents;
  • Non-Steroidal [CS];
  • Cyclooxygenase Inhibitor [EPC];
  • Cyclooxygenase Inhibitors [MoA];
  • Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Labeler Name: Advanced Rx Pharmacy of Tennessee, LLC
FDA Application Number: ANDA074754
Marketing Category: ANDA
Start Marketing Date:6/17/1998

Package Information

No. Package Code Package Description Billing Unit
180425-0139-130 TABLET, FILM COATED in 1 BOTTLE (80425-0139-1)
280425-0139-29 TABLET, FILM COATED in 1 BOTTLE (80425-0139-2)
380425-0139-320 TABLET, FILM COATED in 1 BOTTLE (80425-0139-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC80425-0139The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEKetorolac TromethamineThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEKetorolac TromethamineThe 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 DATE6/17/1998This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at under Structured Product Labeling Resources.
APPLICATION NUMBERANDA074754This 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 NAMEAdvanced Rx Pharmacy of Tennessee, LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEKETOROLAC TROMETHAMINEAn 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.
PHARM CLASSESAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitor [EPC], Cyclooxygenase Inhibitors [MoA], Nonsteroidal Anti-inflammatory Drug [EPC] 

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This page was last updated on: 2/1/2023