Ocuvel
Ocuvel CapsulesRx Only
Approved
Approval ID
888dde46-a454-41cf-9a7a-31fca36e9202
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 3, 2014
Manufacturers
FDA
Adler-Stern Pharmaceuticals, LLC
DUNS: 079403232
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ocuvel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69054-210
Product Classification
G
Generic Name
Ocuvel
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2014
FDA Product Classification
INGREDIENTS (12)
Folic AcidActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
ASCORBIC ACIDActive
Quantity: 500 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
Zinc oxideActive
Quantity: 80 mg in 1 1
Code: SOI2LOH54Z
Classification: ACTIB
LuteinActive
Quantity: 10 mg in 1 1
Code: X72A60C9MT
Classification: ACTIB
ZeaxanthinActive
Quantity: 2 mg in 1 1
Code: CV0IB81ORO
Classification: ACTIB
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ALPHA-TOCOPHEROL ACETATEActive
Quantity: 400 [iU] in 1 1
Code: 9E8X80D2L0
Classification: ACTIB
CopperActive
Quantity: 2 mg in 1 1
Code: 789U1901C5
Classification: ACTIB
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT