VITAMIN D
VITAMIN D (Ergocalciferol Capsules, USP)1.25mg (50,000 USP Units) Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units.
Approved
Approval ID
3c0f4142-cc1f-43de-8677-ee06b6f4fc10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 28, 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 Code71610-552
Application NumberANDA090455
Product Classification
M
Marketing Category
C73584
G
Generic Name
ergocalciferol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2023
FDA Product Classification
INGREDIENTS (11)
ERGOCALCIFEROLActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB
FD&C YELLOW NO. 5Inactive
Code: I753WB2F1M
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
ETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: IDK7C2HS09
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT