Prescription drug · NDA
Iluvien (Fluocinolone acetonide) NDC 68611-190
Fluocinolone acetonide .19 mg/1 · Implant · Intravitreal · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68611-190-02 | 6861101900268611019002 | 1 TRAY in 1 CARTON (68611-190-02) / 1 APPLICATOR in 1 TRAY / 1 IMPLANT in 1 APPLICATORMarketed from Oct 15, 2014 |
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)
- Iluvien
- Generic name (nonproprietary)
- fluocinolone acetonide
- Active ingredients
- Fluocinolone acetonide — .19 mg/1
- Dosage form
- Implant
- Route
- Intravitreal
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 68611
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 201923
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 68611-190_78b978f0-fc11-11f0-b558-0800200c9a66SPL ID 78b978f0-fc11-11f0-b558-0800200c9a66SPL set ID 4400e471-7402-11df-93f2-0800200c9a66RxCUI 1552351, 1552356UNII 0CD5FD6S2M
- Pharmacologic class
- Corticosteroid
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N468611019002followed by a unit qualifier and the quantityPackage 68611-0190-02. 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)
ILUVIEN is a corticosteroid indicated for: the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. (1.1) the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. (1.2) 1.1 Diabetic Macular Edema ILUVIEN ® is indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. 1.2 Chronic Non-Infectious Uveitis Affecting the Posterior Segment ILUVIEN ® is indicated for the treatment…
Excerpt only. Read the full label for complete information.
About NDC 68611-190
- What is NDC 68611-190?
- 68611-190 is the product NDC for Iluvien (fluocinolone acetonide), Fluocinolone acetonide .19 mg/1 implant, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Iluvien (Fluocinolone acetonide).
- What is the active ingredient?
- Fluocinolone acetonide.
- Who is the labeler?
- ANI Pharmaceuticals, Inc., NDC labeler code 68611. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Iluvien?
- 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.