Home NDC 87628-101 Varubi
Product NDC 87628-101
11-digit product format 876280101
Labeler code 87628
Product ID 87628-101_25c6e790-1e90-4901-b85b-f24d2c8c2b04
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rolapitant
Dosage form TABLET
Route ORAL
Labeler Luria Therapeutics LLC
Application NDA206500
Marketing category NDA
Marketing start 2026-08-20
Substance ROLAPITANT HYDROCHLORIDE
Active strength 90 mg/1
Pharmacologic classes Breast Cancer Resistance Protein Inhibitors [MoA], Cytochrome P450 2D6 Inhibitors [MoA], Neurokinin 1 Antagonists [MoA], P-Glycoprotein Inhibitors [MoA], Substance P/Neurokinin-1 Receptor Antagonist [EPC]
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 44 .
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 N206500-001 VARUBI ROLAPITANT HYDROCHLORIDE EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206500-001 7563801 2027-04-04 Drug product 2015-09-25 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 N206500-001 8361500 2029-10-09 Drug product 2015-09-25
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.
Product history page 1 of 2 · 44 observed 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 2026-10-15 13:18:30 2026-09 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 3a93d1ddd44b…
Observed Orange Book patent history# Patent history page 1 of 9 · 326 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 c2088c7a36db…2026-10-15 13:18:30 2026-09 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 c2088c7a36db…2026-09-14 22:38:34 2026-08 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 6a471c1ec25d…
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 Varubi
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ROLAPITANT HYDROCHLORIDE 90 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 57O5S1QSAQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1665503 Internal RxNorm lookup 1673373 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87628-101-02 87628010102 2 TABLET in 1 BLISTER PACK (87628-101-02) 2 tablet 2026-09-08 No No Current