Xiidra
- Product NDC
- 54092-606
- 11-digit product format
- 540920606
- Labeler code
- 54092
- Product ID
- 54092-606_2648ebbb-5b5e-4497-adc2-db90088ba884
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lifitegrast
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Takeda Pharmaceuticals America, Inc.
- Application
- NDA208073
- Marketing category
- NDA
- Marketing start
- 2016-07-11
- Marketing end
- 2023-03-31
- 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
- 0000-00-00
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54092-606-01 | 54092060601 | 12 POUCH in 1 CARTON (54092-606-01) > 5 AMPULE in 1 POUCH (54092-606-06) > .2 mL in 1 AMPULE | 12 pouch | 2016-07-11 | 2023-02-28 | No | No | Current |
| 54092-606-02 | 54092060602 | 12 POUCH in 1 CARTON (54092-606-02) > 5 AMPULE in 1 POUCH (54092-606-07) > .2 mL in 1 AMPULE | 12 pouch | 2016-07-11 | 2023-03-31 | No | No | Current |
| 54092-606-04 | 54092060604 | 4 POUCH in 1 CARTON (54092-606-04) > 5 AMPULE in 1 POUCH (54092-606-07) > .2 mL in 1 AMPULE | 4 pouch | 2016-07-11 | 2023-03-31 | No | No | Current |