NDC codes

FDA NDC Directory
Product NDC (as listed)0023-3348Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00023-3348Add 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
0023-3348-07000233348071 POUCH in 1 CARTON (0023-3348-07) / 1 IMPLANT in 1 POUCHMarketed from Sep 1, 2009
0023-3348-08000233348081 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

N400023334807 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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.

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