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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 040833

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NDA 040833 describes ERGOCALCIFEROL, which is a drug marketed by Chartwell Rx, Onesource Specialty, Puracap Pharm Llc, Sigmapharm Labs Llc, and Sun Pharm Inds Inc, and is included in five NDAs. It is available from twenty suppliers. Additional details are available on the ERGOCALCIFEROL profile page.

The generic ingredient in ERGOCALCIFEROL is ergocalciferol. There are six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the ergocalciferol profile page.

Summary for 040833

Tradename:	ERGOCALCIFEROL
Applicant:	Chartwell Rx
Ingredient:	ergocalciferol
Patents:	0

Pharmacology for NDA: 040833

Suppliers and Packaging for NDA: 040833

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	040833	ANDA	Chartwell RX, LLC	62135-439	62135-439-90	90 CAPSULE in 1 BOTTLE (62135-439-90)
ERGOCALCIFEROL	ergocalciferol	CAPSULE;ORAL	040833	ANDA	Alembic Pharmaceuticals Inc.	62332-464	62332-464-31	100 CAPSULE in 1 BOTTLE (62332-464-31)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	50,000 IU
Approval Date:	May 20, 2009	TE:	AA	RLD:	No

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