75834-337 NDC - DICLOFENAC POTASSIUM (DICLOFENAC POTASSIUM TABLETS)

Drug Information

  • Product NDC: 75834-337
  • Proprietary Name: Diclofenac Potassium
  • Non Proprietary Name: Diclofenac Potassium Tablets
  • Active Ingredient(s): 25 mg/1 DICLOFENAC POTASSIUM
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Anti-Inflammatory Agents; Non-Steroidal [CS]; Cyclooxygenase Inhibitors [MoA]; Decreased Prostaglandin Production [PE]; Nonsteroidal Anti-inflammatory Drug [EPC]

Labeler Information

Field Name Field Value
Labeler Name: NIVAGEN PHARMACEUTICALS, INC.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA215750
Marketing Category: ANDA
Start Marketing Date:10/10/2025

Package Information

No. Package Code Package Description Billing Unit
175834-337-3030 TABLET, FILM COATED in 1 BOTTLE (75834-337-30)EA
275834-337-6060 TABLET, FILM COATED in 1 BOTTLE (75834-337-60)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC75834-337The 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 NAMEDiclofenac PotassiumThe 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.
NON PROPRIETARY NAMEDiclofenac Potassium TabletsIndicates 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.
DOSAGE FORM NAMETABLET, FILM COATEDThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
ROUTE NAMEORALThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE10/10/2025This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAThis is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
APPLICATION NUMBERANDA215750This 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 NAMENIVAGEN PHARMACEUTICALS, INC.This 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.
SUBSTANCE NAMEDICLOFENAC POTASSIUMName of Company corresponding to the labeler code segment of the Product NDC.
ACTIVE NUMERATOR STRENGTH25An 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 INGRED UNITmg/1 
PHARM CLASSESAnti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC] 

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This page was last updated on: 1/2/2026

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