MedPath

PIRMELLA 1/35

Pirmella™ 1/35(norethindrone and ethinyl estradiol tablets USP)1 mg/0.035 mgRx Only

Approved
Approval ID

bb21b098-284a-4cad-bf8f-a062e88a3d56

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 9, 2013

Manufacturers
FDA

Lupin Pharmaceuticals, Inc.

DUNS: 089153071

Products 1

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

NORETHINDRONE AND ETHINYL ESTRADIOL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68180-893
Application NumberANDA201512
Product Classification
M
Marketing Category
C73584
G
Generic Name
NORETHINDRONE AND ETHINYL ESTRADIOL
Product Specifications
Effective DateDecember 9, 2013
FDA Product Classification

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

PIRMELLA 1/35 - FDA Drug Approval Details