FDA Product

Ergocalciferol

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

Basic Information

Product Name

Ergocalciferol

FDA Product Code

42291-266

Regulatory Information

NDC Product Code

42291-266

Application Number

ANDA080704

Marketing Category

C73584

Effective Date

January 13, 2022

Territorial Authority

USA

FDA Title

Ergocalciferol Capsules, USP

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

7

Company Information

ManufacturerAvKARE

DUNS Number

796560394

Active Ingredients

SOYBEAN OIL

Code: 241ATL177A

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

Quantity: 1.25 mg in 1 1

Code: VS041H42XC

Class Code: ACTIB

GELATIN

Code: 2G86QN327L

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

Active Moieties

ERGOCALCIFEROL

Code: VS041H42XC

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