Xiidra
- Product NDC
- 0078-0911
- 11-digit product format
- 000780911
- Labeler code
- 0078
- Product ID
- 0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lifitegrast
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Novartis Pharmaceuticals Corporation
- Application
- NDA208073
- Marketing category
- NDA
- Marketing start
- 2016-07-11
- Substance
- LIFITEGRAST
- Active strength
- 50 mg/mL
- Pharmacologic classes
- Lymphocyte Function-Associated Antigen-1 Antagonist [EPC], Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Xiidra
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LIFITEGRAST | 50 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 038E5L962W |
| Rxcui | 1801835, 1801840 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0078-0911-05 | Xiidra | 0.2 mL in 1 AMPULE | SOLUTION/ DROPS | 0.2 | | 6 |
| 0078-0911-05 | Xiidra | 5 in 1 POUCH | SOLUTION/ DROPS | 5 | | 6 |
| 0078-0911-12 | Xiidra | 12 in 1 CARTON | SOLUTION/ DROPS | 12 | | 6 |
| 0078-0911-94 | Xiidra | 4 in 1 CARTON | SOLUTION/ DROPS | 4 | | 6 |
| 0078-0911-95 | Xiidra | 5 in 1 POUCH | SOLUTION/ DROPS | 5 | | 6 |
| 0078-0911-95 | Xiidra | 0.2 mL in 1 AMPULE | SOLUTION/ DROPS | 0.2 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0078-0911 | XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [NOVARTIS PHARMACEUTICALS CORPORATION] | 5 | Current NDC, Legacy NDC, 6 package rows | 20230803_8589d376-ac10-4ddb-9c53-2e0c8d5675c4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0078-0911-05 | 00078091105 | 0.2 mL in 1 AMPULE | 0.2 ml | | | | | Historical |
| 0078-0911-12 | 00078091112 | 12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE | 12 pouch | 2020-06-04 | 2027-06-01 | No | No | Current |
| 0078-0911-94 | 00078091194 | 4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE | 4 pouch | 2020-06-04 | 2027-02-01 | Yes | No | Current |
| 0078-0911-95 | 00078091195 | 5 in 1 POUCH | | | | | | Historical |