Last Updated: June 13, 2026

Details for New Drug Application (NDA): 064126

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NDA 064126 describes ERYTHROMYCIN, which is a drug marketed by Barr, Carnegie, Encube, Fougera Pharms, Padagis Us, Elkins Sinn, Bausch And Lomb, Pharmaderm, Pharmafair, Sentiss, Paddock Llc, Alpharma Us Pharms, Bausch, Lilly, Pai Holdings Pharm, Pharmobedient Cnsltg, Renaissance Pharma, Epic Pharma Llc, Pharmobedient, Amneal Pharms Co, Torrent, Abon Pharms Llc, Alembic, Alkem Labs Ltd, Cadila Pharms Ltd, Teva Pharms Usa Inc, Zydus Lifesciences, Zydus Pharms, Rising, Ivax Sub Teva Pharms, Watson Labs, Cosette, Life Labs, Amneal Pharms, Ani Pharms, Ph Health, Dista, Naska, Parke Davis, Aurobindo Pharma Usa, Abraxis Pharm, Baxter Hlthcare, Exela Pharma, Gland, Nexus, Teva Parenteral, Lederle, and Purepac Pharm, and is included in seventy-eight NDAs. It is available from thirty-one suppliers. Additional details are available on the ERYTHROMYCIN profile page.

The generic ingredient in ERYTHROMYCIN is erythromycin stearate. There are one hundred and three drug master file entries for this compound. Additional details are available on the erythromycin stearate profile page.

Summary for 064126

Tradename:	ERYTHROMYCIN
Applicant:	Padagis Us
Ingredient:	erythromycin
Patents:	0

Pharmacology for NDA: 064126

Physiological Effect	Decreased Sebaceous Gland Activity

Medical Subject Heading (MeSH) Categories for 064126

Anti-Bacterial Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors

Suppliers and Packaging for NDA: 064126

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERYTHROMYCIN	erythromycin	SWAB;TOPICAL	064126	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-962	45802-962-72	60 APPLICATOR in 1 JAR (45802-962-72) / .8 mL in 1 APPLICATOR
ERYTHROMYCIN	erythromycin	SWAB;TOPICAL	064126	ANDA	Bryant Ranch Prepack	63629-8648	63629-8648-1	60 APPLICATOR in 1 JAR (63629-8648-1) / .8 mL in 1 APPLICATOR

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SWAB;TOPICAL			Strength	2%
Approval Date:	Jul 3, 1996	TE:	AT	RLD:	No

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