Prescription drug · NDA
Zioptan (Tafluprost) NDC 82584-609
Tafluprost .015 mg/mL · Solution/ drops · Ophthalmic · Thea Pharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82584-609-30 | 8258406093082584060930 | 3 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
N482584060930followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Tafluprost Ophthalmictafluprost | Tafluprost .0045 mg/.3mL | Solution/ dropsOphthalmic | Prasco Laboratories | 66993-429 |