Home NDC 69656-101-02 Varubi
Product NDC 69656-101
Requested package NDC 69656-101-02
11-digit product format 696560101
Labeler code 69656
Product ID 69656-101_41a8662a-8aa7-4c63-8fc6-b29286e08ac8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name rolapitant
Dosage form TABLET
Route ORAL
Labeler GlaxoSmithLine LLC
Application NDA206500
Marketing category NDA
Marketing start 2015-10-07
Marketing end 2021-10-31
Substance ROLAPITANT HYDROCHLORIDE
Active strength 90 mg/1
Pharmacologic classes Neurokinin 1 Antagonists [MoA],Substance P/Neurokinin-1 Receptor Antagonist [EPC],Cytochrome P450 2D6 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 · 41 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 2026-02-19 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…2022-10-28 04:53 UTC 2022-10 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N206500-001 VARUBI EQ 90MG BASE TABLET / ORAL RLD, RS 2015-09-01 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 8 · 305 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 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…2025-08-23 18:47 UTC 2025-08 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 8470842 2029-01-18 U-1741 2015-09-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206500-001 8361500 2029-10-09 Drug product 2015-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206500-001 7563801 2027-04-04 Drug product 2015-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206500-001 7981905 2027-04-04 U-1741 2015-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206500-001 8178550 2027-04-04 Drug substance, Drug product 2015-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206500-001 8404702 2027-04-04 U-1741 2015-09-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206500-001 7049320 2028-08-19 U-1741 Drug substance, Drug product 2015-09-25 03ed91905a0d…
Observed Orange Book exclusivity history# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ROLAPITANT HYDROCHLORIDE ACTIVE INGREDIENT 57O5S1QSAQ VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 ROLAPITANT ACTIVE MOIETY NLE429IZUC VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ VARUBI (ROLAPITANT) TABLET [TESARO, INC.] 3
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Varubi ROLAPITANT TerSera Therapeutics LLC a52896cd-4a98-49b8-82db-bf1985a64d97 2020-08-19 Warnings, Adverse reactions Exact identifier application applno (NDA): 206500 application number: NDA206500
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69656-101-02 69656010102 2 TABLET in 1 BLISTER PACK (69656-101-02) 2 tablet 2015-10-07 2021-10-31 No No Current