Prescription drug · NDA
Ozurdex (Dexamethasone) NDC 0023-3348
Dexamethasone .7 mg/1 · Implant · Intravitreal · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-3348-07 | 00023334807 | 1 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCHMarketed from Sep 1, 2009 | |
| 0023-3348-08 | 00023334808 | 1 POUCH in 1 CARTON (0023-3348-08) / 1 IMPLANT in 1 POUCHMarketed from Sep 1, 2009 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Ozurdex
- Generic name (nonproprietary)
- dexamethasone
- Active ingredients
- Dexamethasone — .7 mg/1
- Dosage form
- Implant
- Route
- Intravitreal
- Labeler
- Allergan, Inc.NDC labeler code 0023
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022315
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 0023-3348_007c310d-2cfe-4c54-a27e-693e0d7fa78aSPL ID 007c310d-2cfe-4c54-a27e-693e0d7fa78aSPL set ID 4b204f44-6e8a-4d17-803c-268f0b04679fRxCUI 854177, 854181UNII 7S5I7G3JQL
- 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
N400023334807followed by a unit qualifier and the quantityPackage 00023-3348-07. 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)
OZURDEX is a corticosteroid indicated for: The treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) ( 1.1 ) The treatment of non-infectious uveitis affecting the posterior segment of the eye ( 1.2 ) The treatment of diabetic macular edema ( 1.3 ) 1.1 Retinal Vein Occlusion OZURDEX ® (dexamethasone intravitreal implant) is indicated for the treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). 1.2 Posterior Segment Uveitis OZURDEX is indicated for the treatment of non-infectious uveitis affecting the posterior segment of the eye. 1.3 Diabetic Macular Edema OZURDEX is ind…
Excerpt only. Read the full label for complete information.
About NDC 0023-3348
- What is NDC 0023-3348?
- 0023-3348 is the product NDC for Ozurdex (dexamethasone), Dexamethasone .7 mg/1 implant, listed with the FDA by Allergan, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ozurdex (Dexamethasone).
- What is the active ingredient?
- Dexamethasone.
- Who is the labeler?
- Allergan, Inc., NDC labeler code 0023. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ozurdex?
- 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.