Diclofenac Sodium NDC 61314-014

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-014Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0014Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
61314-014-05	61314001405	1 BOTTLE in 1 CARTON (61314-014-05) / 5 mL in 1 BOTTLEMarketed from Feb 14, 2018
61314-014-25	61314001425	1 BOTTLE in 1 CARTON (61314-014-25) / 2.5 mL in 1 BOTTLEMarketed from Feb 14, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Diclofenac Sodium
Generic name (nonproprietary): diclofenac sodium
Active ingredients: Diclofenac sodium — 1 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz Inc
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078031
Marketing start: Feb 14, 2008
Listing expires: Dec 31, 2026
Other FDA classes: Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)
Identifiers: Product ID 61314-014_202278f8-31f7-4c24-ae96-8065430d6a7dSPL ID 202278f8-31f7-4c24-ae96-8065430d6a7dSPL set ID 52d22a6b-3acd-4694-9df5-8cfa9cc2bb2bRxCUI 854801UNII QTG126297Q
Pharmacologic class: Nonsteroidal Anti-inflammatory Drug

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N461314001405 followed by a unit qualifier and the quantity

Package 61314-0014-05. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Sep 29, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Diclofenac sodium ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078031

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 078031
Product	Strength	Form · route	Labeler	Product NDC
Diclofenac Sodium	Diclofenac sodium 1 mg/mL	SolutionOphthalmic	A-S Medication Solutions	50090-3568