LUPKYNIS
- Product NDC
- 75626-001
- 11-digit product format
- 756260001
- Labeler code
- 75626
- Product ID
- 75626-001_413a060a-faf5-af00-e063-6394a90af847
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Voclosporin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- Aurinia Pharma U.S., Inc.
- Application
- NDA213716
- Marketing category
- NDA
- Marketing start
- 2021-01-22
- Substance
- VOCLOSPORIN
- Active strength
- 7.9 mg/1
- Pharmacologic classes
- Calcineurin Inhibitor Immunosuppressant [EPC], Calcineurin Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUPKYNIS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| VOCLOSPORIN | 7.9 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2PN063X6B1 |
| Rxcui | 2475400, 2475406 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 75626-001-01 | LUPKYNIS | 4 in 1 PACKET | CAPSULE | 4 | | 11 |
| 75626-001-01 | LUPKYNIS | 15 in 1 BLISTER PACK | CAPSULE | 15 | | 11 |
| 75626-001-02 | LUPKYNIS | 3 in 1 CARTON | CAPSULE | 3 | | 11 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 75626-001 | LUPKYNIS (VOCLOSPORIN) CAPSULE [AURINIA PHARMA U.S., INC.] | 10 | Current NDC, Legacy NDC, 3 package rows | 20241215_9f489295-1156-52c7-5fd0-5c4c52f9b813.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 |
|---|
| 75626-001-01 | 75626000101 | 4 in 1 PACKET | | | | | | Historical |
| 75626-001-02 | 75626000102 | 3 PACKET in 1 CARTON (75626-001-02) / 4 BLISTER PACK in 1 PACKET (75626-001-01) / 15 CAPSULE in 1 BLISTER PACK | 3 packet | 2021-01-22 | 0000-00-00 | No | No | Current |