0310-0951 NDC - ZOLADEX (GOSERELIN ACETATE)

Drug Information

Product NDC: 0310-0951

Proprietary Name: ZOLADEX

Non Proprietary Name: Goserelin acetate

Active Ingredient(s):
  • 10.8 mg/1 GOSERELIN ACETATE


Administration Route(s): SUBCUTANEOUS

Dosage Form(s): IMPLANT

Pharmacy Class(es):
  • Gonadotropin Releasing Hormone Receptor Agonist [EPC];
  • Gonadotropin Releasing Hormone Receptor Agonists [MoA]

Labeler Information

Labeler Name: AstraZeneca Pharmaceuticals LP
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: NDA020578
Marketing Category: NDA
Start Marketing Date:5/5/2003
End Marketing Date:3/31/2020

Package Information

No. Package Code Package Description Billing Unit
10310-0951-301 POUCH in 1 CARTON (0310-0951-30) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC0310-0951The 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 NAMEZOLADEXThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEGoserelin acetateThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEIMPLANTThe translation of the dosage form Code submitted by the firm.
ROUTE NAMESUBCUTANEOUSThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE5/5/2003This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE3/31/2020This 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 NAMENDAProduct 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 NUMBERNDA020578This 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 NAMEAstraZeneca Pharmaceuticals LPName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEGOSERELIN ACETATEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH10.8 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESGonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA] 

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This page was last updated on: 10/4/2019