MedPath

Ergocalciferol

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

Approved
Approval ID

a8bab53a-2c6a-403a-b9a8-564fa3592c71

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jul 1, 2014

Manufacturers
FDA

ReadyMeds

DUNS: 072115132

Products 1

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

Ergocalciferol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64205-157
Application NumberANDA091004
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergocalciferol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 1, 2014
FDA Product Classification

INGREDIENTS (11)

SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
ERGOCALCIFEROLActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT

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