Home NDC 75626-001-02 LUPKYNIS
Product NDC 75626-001
Requested package NDC 75626-001-02
11-digit product format 756260001
Labeler code 75626
Product ID 75626-001_59e563df-ed2e-4a55-e063-6294a90a0b51
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 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N213716-001 LUPKYNIS VOCLOSPORIN 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213716-001 7332472 2027-10-17 U-3056 Drug substance, Drug product 2021-02-11 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 N213716-001 11622991 2037-12-07 U-3056 2023-05-05
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213716-001 NCE 2026-01-22
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213716-001 LUPKYNIS 7.9MG CAPSULE / ORAL RLD, RS 2021-01-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 96 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N213716-001 7332472 2027-10-17 U-3056 Drug substance, Drug product 2021-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213716-001 7332472 2027-10-17 U-3056 Drug substance, Drug product 2021-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213716-001 7332472 2027-10-17 U-3056 Drug substance, Drug product 2021-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213716-001 7332472 2026-01-17 U-3056 Drug substance, Drug product 2021-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213716-001 7332472 2024-10-17 U-3056 Drug substance, Drug product 2021-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213716-001 7332472 2025-10-17 U-3056 Drug substance, Drug product 2021-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213716-001 7332472 2024-10-17 U-3056 Drug substance, Drug product 2021-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213716-001 10286036 2037-12-07 U-3056 2021-02-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213716-001 11622991 2037-12-07 U-3056 2023-05-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213716-001 7332472 2024-10-17 U-3056 Drug substance, Drug product 2021-02-11 301d65b070ca…
Observed Orange Book exclusivity history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base LUPKYNIS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VOCLOSPORIN 7.9 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2PN063X6B1 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2475400 Internal RxNorm lookup 2475406 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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 75626-001-02 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