Lifitegrast
- Product NDC
- 59651-450
- 11-digit product format
- 596510450
- Labeler code
- 59651
- Product ID
- 59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lifitegrast
- Dosage form
- FOR SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Aurobindo Pharma Limited
- Application
- ANDA215063
- Marketing category
- ANDA
- Marketing start
- 2023-11-07
- 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
- Lifitegrast
- 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 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59651-450-05 | Lifitegrast | 0.2 mL in 1 AMPULE | FOR SOLUTION | 0.2 | | 1 |
| 59651-450-05 | Lifitegrast | 5 in 1 POUCH | FOR SOLUTION | 5 | | 1 |
| 59651-450-60 | Lifitegrast | 60 in 1 CARTON | FOR SOLUTION | 60 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59651-450 | LIFITEGRAST FOR SOLUTION [AUROBINDO PHARMA LIMITED] | 1 | Current NDC, 3 package rows | 20231115_1d4b4b61-79da-4b6f-bb19-056d111bf400.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 59651-450-05 | 59651045005 | 0.2 mL in 1 AMPULE | 0.2 ml | | | | Historical |
| 59651-450-60 | 59651045060 | 60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULE | 60 pouch | 2023-11-07 | No | No | Historical |