Ergocalciferol
VITAMIN D, ERGOCALCIFEROL Capsules, USP, 1.25 mg SOFTGEL CAPSULES (Soft Gelatin Capsules) (50,000 USP Units)
Approved
Approval ID
4bedecb7-8c37-4a1c-81f6-0adfed636f37
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 11, 2017
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 Code43353-219
Application NumberANDA040833
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergocalciferol
Product Specifications
Route of AdministrationORAL
Effective DateMay 26, 2017
FDA Product Classification
INGREDIENTS (7)
ErgocalciferolActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB
D&C Yellow No. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C Blue No. 1Inactive
Code: H3R47K3TBD
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Soybean OilInactive
Code: 241ATL177A
Classification: IACT