What is NDC 61314-665?

61314-665 is the product NDC for Apraclonidine, Apraclonidine hydrochloride 5.75 mg/mL solution, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Apraclonidine?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Apraclonidine NDC 61314-665 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)61314-665Labeler and product segments. Claims need a package NDC.

Product NDC at billing width61314-0665Add 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
61314-665-05	61314066505	5 mL in 1 BOTTLE (61314-665-05)Marketed from Jul 19, 2009
61314-665-10	61314066510	10 mL in 1 BOTTLE (61314-665-10)Marketed from Jul 19, 2009

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): Apraclonidine
Generic name (nonproprietary): apraclonidine
Active ingredients: Apraclonidine hydrochloride — 5.75 mg/mL
Dosage form: Solution
Route: Ophthalmic
Labeler: Sandoz IncNDC labeler code 61314
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020258
Marketing start: Jul 19, 2009
Listing expires: Dec 31, 2026
Other FDA classes: Adrenergic alpha-Agonists (Mechanism)
Identifiers: Product ID 61314-665_238af96f-2f89-9af4-e063-6394a90a9516SPL ID 238af96f-2f89-9af4-e063-6394a90a9516SPL set ID 04ad82af-e7ba-4f40-a120-be9d33cf0c7bRxCUI 308345UNII D2VW67N38HUPC 0361314665058, 0361314665102
Pharmacologic class: alpha-Adrenergic Agonist

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

N461314066505 followed by a unit qualifier and the quantity

Package 61314-0665-05. 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 Oct 2, 2024.

Indications (excerpt from the label)

INDICATIONS AND USAGE Apraclonidine ophthalmic solution 0.5% is indicated for short-term adjunctive therapy, in patients on maximally tolerated medical therapy, who require additional IOP reduction. Patients on maximally tolerated medical therapy, who are treated with apraclonidine ophthalmic solution 0.5% to delay surgery, should have frequent follow-up examinations and treatment should be discontinued if the IOP rises significantly. The addition of apraclonidine ophthalmic solution 0.5% to patients already using two aqueous suppressing drugs (i.e., beta-blocker plus carbonic anhydrase inhibitor) as part of their maximally tolerated medical therapy may not provide additional benefit. This i…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 61314-665

What is NDC 61314-665?: 61314-665 is the product NDC for Apraclonidine, Apraclonidine hydrochloride 5.75 mg/mL solution, listed with the FDA by Sandoz Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Apraclonidine.
What is the active ingredient?: Apraclonidine hydrochloride.
Who is the labeler?: Sandoz Inc, NDC labeler code 61314. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Apraclonidine?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.