Ergocalciferol Capsules,
Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units
Approved
Approval ID
e58cfb46-f8a7-4327-bbe8-da4d4be2bd1d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2019
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ergocalciferol Capsules,
PRODUCT DETAILS
NDC Product Code42806-547
Application NumberANDA204276
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 31, 2019
Generic NameErgocalciferol Capsules,
INGREDIENTS (11)
ERGOCALCIFEROLActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB
BUTYLATED HYDROXYANISOLEInactive
Code: REK4960K2U
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT