Ergocalciferol
Ergocalciferol Capsules, USP
Approved
Approval ID
53b1ee91-c4e0-450a-8bd1-1220da0daedf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 11, 2015
Manufacturers
FDA
Banner Life Sciences LLC.
DUNS: 079579273
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 Code69387-106
Application NumberANDA080704
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ergocalciferol
Product Specifications
Route of AdministrationORAL
Effective DateJune 11, 2015
FDA Product Classification
INGREDIENTS (7)
SOYBEAN OILInactive
Code: 241ATL177A
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
ErgocalciferolActive
Quantity: 1.25 mg in 1 1
Code: VS041H42XC
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 5/15/2015
Manufactured for:
Banner Life Sciences LLC.
High Point, NC 27265
Rev. 02/2015