Prescription drug · NDA
Xiidra (Lifitegrast) NDC 0078-0911
Lifitegrast 50 mg/mL · Solution/ drops · Ophthalmic · Novartis Pharmaceuticals Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0078-0911-12 | 00078091112 | 12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULEMarketed from Jun 4, 2020 | |
| 0078-0911-94 | 00078091194 | 4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULEMarketed from Jun 4, 2020 · 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)
- Xiidra
- Generic name (nonproprietary)
- lifitegrast
- Active ingredients
- Lifitegrast — 50 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- Novartis Pharmaceuticals CorporationNDC labeler code 0078
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208073
- Marketing start
- Listing expires
- Other FDA classes
- Lymphocyte Function-Associated Antigen-1 Antagonists (Mechanism)
- Identifiers
- Product ID 0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931SPL ID 3cabbaea-c2bf-971c-e063-6394a90a4931SPL set ID 8589d376-ac10-4ddb-9c53-2e0c8d5675c4RxCUI 1801835, 1801840UNII 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
N400078091112followed by a unit qualifier and the quantityPackage 00078-0911-12. 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)
Xiidra ® (lifitegrast ophthalmic solution) 5% is indicated for the treatment of the signs and symptoms of dry eye disease (DED). Xiidra (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). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0078-0911
- What is NDC 0078-0911?
- 0078-0911 is the product NDC for Xiidra (lifitegrast), Lifitegrast 50 mg/mL solution/ drops, listed with the FDA by Novartis Pharmaceuticals Corporation. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Xiidra (Lifitegrast).
- What is the active ingredient?
- Lifitegrast.
- Who is the labeler?
- Novartis Pharmaceuticals Corporation, NDC labeler code 0078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Xiidra?
- 1 other product NDC are listed under this name. See all Xiidra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Xiidra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Xiidralifitegrast | Lifitegrast 50 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-911 | 24208-0911-1224208-0911-94 |
Other NDCs under NDA 208073
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Xiidralifitegrast | Lifitegrast 50 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-911 |