Vitamin D
Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
Approved
Approval ID
bc815c71-a973-0ff9-e053-2995a90a8b04
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 22, 2022
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-2352
Application NumberANDA204276
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergocalciferol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 22, 2022
FDA Product Classification
INGREDIENTS (11)
SHELLACInactive
Code: 46N107B71O
Classification: IACT
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
ERGOCALCIFEROLActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB