Estradiol by Qualgen LLC

Estradiol by

Drug Labeling and Warnings

Estradiol by is a Prescription medication manufactured, distributed, or labeled by Qualgen LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ESTRADIOL- estradiol pellet 
Qualgen LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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estradiol 12mg pellet

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ESTRADIOL 
estradiol pellet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 69761-012
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E)	ESTRADIOL	12.5 mg

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69761-012-12	12 in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2015
2	NDC: 69761-012-30	30 in 1 PACKAGE; Type 0: Not a Combination Product	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/01/2015	10/04/2021

Labeler - Qualgen LLC (034474862)

Revised: 9/2021

Document Id: cd010854-ba37-f5bf-e053-2a95a90a7b7a

34391-3

Set id: f6e35257-b9b2-4919-9526-6304e6fa8a94

Version: 9

Effective Time: 20210927