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
NDC Product Code69387-106
Application NumberANDA080704
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 11, 2015
Generic NameErgocalciferol
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