What is NDC 59651-450?

59651-450 is the product NDC for Lifitegrast, Lifitegrast 50 mg/mL for solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.

Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Lifitegrast?

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.

Lifitegrast NDC 59651-450 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)59651-450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width59651-0450Add 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
59651-450-60	59651045060	60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULEMarketed from Nov 7, 2023

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): Lifitegrast
Generic name (nonproprietary): lifitegrast
Active ingredients: Lifitegrast — 50 mg/mL
Dosage form: For solution
Route: Ophthalmic
Labeler: Aurobindo Pharma LimitedNDC labeler code 59651
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215063
Marketing start: Nov 7, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Lymphocyte Function-Associated Antigen-1 Antagonists (Mechanism)
Identifiers: Product ID 59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400SPL ID 1d4b4b61-79da-4b6f-bb19-056d111bf400SPL set ID 1d4b4b61-79da-4b6f-bb19-056d111bf400RxCUI 1801835UNII 038E5L962W
Pharmacologic class: Lymphocyte Function-Associated Antigen-1 Antagonist

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

N459651045060 followed by a unit qualifier and the quantity

Package 59651-0450-60. 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 Nov 13, 2023.

Indications (excerpt from the label)

Lifitegrast ophthalmic solution 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Lifitegrast ophthalmic solution 5% is a lymphocyte function-associated antigen-1 (LFA-1) antagonist indicated for the treatment of the signs and symptoms of dry eye disease (DED).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-450

What is NDC 59651-450?: 59651-450 is the product NDC for Lifitegrast, Lifitegrast 50 mg/mL for solution, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Lifitegrast.
What is the active ingredient?: Lifitegrast.
Who is the labeler?: Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Lifitegrast?: 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.