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Diclofenac Sodium

Diclofenac Sodium Ophthalmic Solution, 0.1% (Sterile)

Approved
Approval ID

888d7749-bdbc-4788-a215-9c0447aee79a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 24, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Diclofenac Sodium

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-710
Application NumberANDA078792
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diclofenac Sodium
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJune 3, 2010
FDA Product Classification

INGREDIENTS (7)

EDETATE DISODIUMInactive
Quantity: 1 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
DICLOFENAC SODIUMActive
Quantity: 1 mg in 1 mL
Code: QTG126297Q
Classification: ACTIB
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
SORBIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: X045WJ989B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TROMETHAMINEInactive
Code: 023C2WHX2V
Classification: IACT

Drug Labeling Information

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/3/2010

DOSAGE AND ADMINISTRATION

**Cataract Surgery:**One drop of Diclofenac Sodium Ophthalmic should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the post operative period.

**Corneal Refractive Surgery:**One or two drops of Diclofenac Sodium Ophthalmic should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/3/2010

Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

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Diclofenac Sodium - FDA Drug Approval Details