70771-1401 NDC - ESTRADIOL

Drug Information

  • Product NDC: 70771-1401
  • Proprietary Name: estradiol
  • Non Proprietary Name: estradiol
  • Active Ingredient(s): .025 mg/d ESTRADIOL
  • Administration Route(s): TRANSDERMAL
  • Dosage Form(s): PATCH
  • Pharmacy Class(es): Estradiol Congeners [CS]; Estrogen Receptor Agonists [MoA]; Estrogen [EPC]

Labeler Information

Field Name Field Value
Labeler Name: Zydus Lifesciences Limited
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA202985
Marketing Category: ANDA
Start Marketing Date:11/2/2023

Package Information

No. Package Code Package Description Billing Unit
170771-1401-44 POUCH in 1 CARTON (70771-1401-4) / 1 PATCH in 1 POUCH (70771-1401-1) / 7 d in 1 PATCH

NDC Record

Field Name Field Value Definition
PRODUCT NDC70771-1401The translation of the dosage form Code submitted by the firm.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThis is the date that the labeler indicates was the start of its marketing of the drug product.
PROPRIETARY NAMEestradiolProduct 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.
NON PROPRIETARY NAMEestradiolName of Company corresponding to the labeler code segment of the Product NDC.
DOSAGE FORM NAMEPATCHAn 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.
ROUTE NAMETRANSDERMAL 
START MARKETING DATE11/2/2023This 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 www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA202985This 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 NAMEZydus Lifesciences LimitedName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEESTRADIOLAn 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 NUMERATOR STRENGTH.025 
ACTIVE INGRED UNITmg/d 
PHARM CLASSESEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC] 

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This page was last updated on: 12/19/2025

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