0713-0630 NDC - ACYCLOVIR ()

Drug Information

  • Product NDC: 0713-0630
  • Proprietary Name: Acyclovir
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: Cosette Pharmaceuticals, Inc.
Product Type:
FDA Application Number: ANDA205591
Marketing Category: ANDA
Start Marketing Date:11/13/2017
End Marketing Date:10/31/2023

Package Information

No. Package Code Package Description Billing Unit
10713-0630-151 TUBE in 1 CARTON (0713-0630-15) / 15 g in 1 TUBEGM
20713-0630-311 TUBE in 1 CARTON (0713-0630-31) / 30 g in 1 TUBEGM

NDC Record

Field Name Field Value Definition
PRODUCT NDC0713-0630The 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.
PROPRIETARY NAMEAcyclovirThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE11/13/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/31/2023This 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.
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 NUMBERANDA205591This 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 NAMECosette Pharmaceuticals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.

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

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