49349-663 NDC - ISOSORBIDE DINITRATE ()

Drug Information

  • Product NDC: 49349-663
  • Proprietary Name: Isosorbide Dinitrate
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: REMEDYREPACK INC.
Product Type:
FDA Application Number: ANDA086221
Marketing Category: ANDA
Start Marketing Date:1/21/2011
End Marketing Date:8/9/2013

Package Information

No. Package Code Package Description Billing Unit
149349-663-0230 TABLET in 1 BLISTER PACK (49349-663-02)

NDC Record

Field Name Field Value Definition
PRODUCT NDC49349-663The translation of the route code submitted by the firm, indicating route of administration.
PROPRIETARY NAMEIsosorbide DinitrateThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE1/21/2011This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE8/9/2013Product 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 www.fda.gov/edrls under Structured Product Labeling Resources.
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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA086221This 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 NAMEREMEDYREPACK INC.Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 11/21/2025

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