MedPath

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

NDC Product Code69054-210
Application NumberN/A
Marketing CategoryN/A
Route of AdministrationORAL
Effective DateNovember 7, 2014
Generic NameOcuvel

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
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Ocuvel - FDA Approval | MedPath