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Kelnor 1/35

(ethynodiol diacetate and ethinyl estradiol tablets USP)

Approved
Approval ID

cfa297a6-1cc7-4751-b8ea-0e57965f1ca9

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Feb 4, 2023

Manufacturers
FDA

A-S Medication Solutions

DUNS: 830016429

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ethynodiol Diacetate and Ethinyl Estradiol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50090-2191
Application NumberANDA076785
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ethynodiol Diacetate and Ethinyl Estradiol
Product Specifications
Effective DateOctober 19, 2022
FDA Product Classification

Drug Labeling Information

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 10/19/2022

HOW SUPPLIED

Kelnor® 1/35 (28 Day Regimen) (ethynodiol diacetate and ethinyl estradiol tablets USP) is packaged in cartons of six blister card dispensers. Each blister card dispenser contains 21 light yellow, round, flat-faced, beveled- edge, unscored tablets, debossed with stylizedb on one side and14 on the other side and 7 white, round, flat-faced, beveled-edge, unscored placebo tablets, debossed with stylizedb on one side and143 on the other side. Each light yellow tablet contains 1 mg of ethynodiol diacetate, USP and 0.035 mg of ethinyl estradiol, USP. Each white tablet contains inert ingredients.

Available in cartons of six blisters

NDC 0555-9064-58

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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Kelnor 1/35 - FDA Drug Approval Details