Akten (lidocaine hydrochloride anhydrous) NDC 82584-792

NDC codes

FDA NDC Directory

Product NDC (as listed)82584-792Labeler and product segments. Claims need a package NDC.

Product NDC at billing width82584-0792Add 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 NDC	11-digit (billing)	Package	Copy
82584-792-01	82584079201	1 TUBE in 1 CARTON (82584-792-01) / 1 mL in 1 TUBEMarketed from Dec 1, 2022
82584-792-25	82584079225	25 TUBE in 1 CARTON (82584-792-25) / 1 mL in 1 TUBEMarketed from Dec 1, 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): Akten
Generic name (nonproprietary): lidocaine hydrochloride anhydrous
Active ingredients: Lidocaine hydrochloride anhydrous — 35 mg/mL
Dosage form: Gel
Route: Ophthalmic
Labeler: Thea Pharma Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022221
Marketing start: Dec 1, 2022
Listing expires: Dec 31, 2027
Other FDA classes: Amides (Chemical structure)Local Anesthesia (Physiologic effect)
Identifiers: Product ID 82584-792_50281c7f-d484-86d7-e063-6394a90af6ffSPL ID 50281c7f-d484-86d7-e063-6394a90af6ffSPL set ID 70ff9fb7-d323-4fe6-b1b1-6033e05f0749RxCUI 1009462, 1011703UNII EC2CNF7XFPUPC 0382584792015
Pharmacologic class: Amide Local Anesthetic; Antiarrhythmic

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

N482584079201 followed by a unit qualifier and the quantity

Package 82584-0792-01. 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 Apr 23, 2026.

Indications (excerpt from the label)

1- INDICATIONS AND USAGE AKTEN is indicated for ocular surface anesthesia during ophthalmologic procedures in adults and pediatric patients. AKTEN is an amide local anesthetic indicated for ocular surface anesthesia during ophthalmologic procedures. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)