Prescription drug · NDA
Dextenza (Dexamethasone) NDC 70382-204
Dexamethasone .4 mg/1 · Insert · Intracanalicular, Ophthalmic · Ocular Therapeutix, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70382-204-01 | 70382020401 | 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-01) / 1 INSERT in 1 POUCH (70382-204-88)Marketed from Jan 7, 2019 | |
| 70382-204-10 | 70382020410 | 10 POUCH in 1 BOX, UNIT-DOSE (70382-204-10) / 1 INSERT in 1 POUCH (70382-204-88)Marketed from Jan 7, 2019 | |
| 70382-204-99 | 70382020499 | 1 POUCH in 1 BOX, UNIT-DOSE (70382-204-99) / 1 INSERT in 1 POUCH (70382-204-88)Marketed from Jan 7, 2019 |
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)
- Dextenza
- Generic name (nonproprietary)
- dexamethasone
- Active ingredients
- Dexamethasone — .4 mg/1
- Dosage form
- Insert
- Route
- Intracanalicular, Ophthalmic
- Labeler
- Ocular Therapeutix, Inc.NDC labeler code 70382
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208742
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 70382-204_ad2305a4-f888-4800-a31e-1fff3ffee20dSPL ID ad2305a4-f888-4800-a31e-1fff3ffee20dSPL set ID 7514e6b8-c33f-4fbf-8810-ef520e1eb4bdRxCUI 2108015, 2108020UNII 7S5I7G3JQLUPC 0370382204885
- 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
N470382020401followed by a unit qualifier and the quantityPackage 70382-0204-01. 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)
DEXTENZA ® is a corticosteroid indicated for: The treatment of ocular inflammation and pain following ophthalmic surgery in adults and pediatric patients. ( 1.1 ). The treatment of ocular itching associated with allergic conjunctivitis in adults and pediatric patients aged 2 years and older. The use of DEXTENZA is not recommended for the treatment of ocular itching associated with allergic conjunctivitis in pediatric patients who require sedation for the insertion procedure. ( 1.2 ). 1.1 Ocular Inflammation and Pain Following Ophthalmic Surgery DEXTENZA is indicated for the treatment of ocular inflammation and pain following ophthalmic surgery ( 1.1 ). 1.2 Itching Associated with Allergic Co…
Excerpt only. Read the full label for complete information.
About NDC 70382-204
- What is NDC 70382-204?
- 70382-204 is the product NDC for Dextenza (dexamethasone), Dexamethasone .4 mg/1 insert, listed with the FDA by Ocular Therapeutix, Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Dextenza (Dexamethasone).
- What is the active ingredient?
- Dexamethasone.
- Who is the labeler?
- Ocular Therapeutix, Inc., NDC labeler code 70382. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Dextenza?
- 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.