Ergocalciferol
Vitamin D (Ergocalciferol Capsules, USP)
Approved
Approval ID
c538ac91-2507-4f42-8f7a-013510539b30
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 7, 2023
Manufacturers
FDA
Aphena Pharma Solutions - Tennessee, LLC
DUNS: 128385585
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 Code71610-712
Application NumberANDA080704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergocalciferol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 18, 2023
FDA Product Classification
INGREDIENTS (7)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ERGOCALCIFEROLActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT