FDA Product

Ergocalciferol

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Product Name

Ergocalciferol

FDA Product Code

64205-157

Regulatory Information

NDC Product Code

64205-157

Application Number

ANDA091004

Marketing Category

C73584

Effective Date

July 1, 2014

Territorial Authority

USA

FDA Title

VITAMIN D (Ergocalciferol Capsules, USP) 1.25 mg (50,000 USP Units)

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

3

Company Information

ManufacturerReadyMeds

DUNS Number

072115132

Active Ingredients

SOYBEAN OIL

Code: 241ATL177A

Class Code: IACT

POLYSORBATE 80

Code: 6OZP39ZG8H

Class Code: IACT

Quantity: 1.25 mg in 1 1

Code: VS041H42XC

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

BUTYLPARABEN

Code: 3QPI1U3FV8

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

SODIUM LAURYL SULFATE

Code: 368GB5141J

Class Code: IACT

Active Moieties

ERGOCALCIFEROL

Code: VS041H42XC

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