NDC codes

FDA NDC Directory
Product NDC (as listed)82584-609Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82584-0609Add 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 NDC11-digit (billing)PackageCopy
82584-609-3082584060930825840609303 POUCH in 1 CARTON (82584-609-30) / 10 VIAL, SINGLE-USE in 1 POUCH (82584-609-01) / .3 mL in 1 VIAL, SINGLE-USEMarketed from Oct 28, 2022

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)
Zioptan
Generic name (nonproprietary)
tafluprost
Active ingredients
Tafluprost — .015 mg/mL
Dosage form
Solution/ drops
Route
Ophthalmic
Labeler
Thea Pharma Inc.NDC labeler code 82584
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 202514
Marketing start
Listing expires
Other FDA classes
Increased Prostaglandin Activity (Physiologic effect)Prostaglandin Receptor Agonists (Mechanism)Prostaglandins (Chemical structure)
Identifiers
Product ID 82584-609_50281dbf-7a22-69dc-e063-6294a90a2cb9SPL ID 50281dbf-7a22-69dc-e063-6294a90a2cb9SPL set ID db529b54-2ac7-4020-9791-7333bbe6c90fRxCUI 1244611, 1244616UNII 1O6WQ6T7G3
Pharmacologic class
Prostaglandin Analog

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

N482584060930 followed by a unit qualifier and the quantity

Package 82584-0609-30. 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 .

Indications (excerpt from the label)

ZIOPTAN® is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ZIOPTAN is a prostaglandin analog indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 82584-609

What is NDC 82584-609?
82584-609 is the product NDC for Zioptan (tafluprost), Tafluprost .015 mg/mL solution/ drops, listed with the FDA by Thea Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Zioptan (Tafluprost).
What is the active ingredient?
Tafluprost.
Who is the labeler?
Thea Pharma Inc., NDC labeler code 82584. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Zioptan?
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.

Other NDCs under NDA 202514

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

FDA NDC Directory listings under NDA 202514
ProductStrengthForm · routeLabelerProduct NDC
Tafluprost OphthalmictafluprostTafluprost .0045 mg/.3mLSolution/ dropsOphthalmicPrasco Laboratories66993-429

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