Home NDC 81672-5051 VTAMA
Product NDC 81672-5051
11-digit product format 816725051
Labeler code 81672
Product ID 81672-5051_4615ce09-cf4d-4410-91ff-db3caea7a802
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name tapinarof
Dosage form CREAM
Route TOPICAL
Labeler Organon LLC
Application NDA215272
Marketing category NDA
Marketing start 2025-05-28
Substance TAPINAROF
Active strength 10 mg/g
Pharmacologic classes Aryl Hydrocarbon Receptor Agonist [EPC], Aryl Hydrocarbon Receptor Agonists [MoA]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 N215272-001 VTAMA TAPINAROF 1% CREAM / TOPICAL RLD, RS 2022-05-23
Orange Book patents# Current patent rows page 1 of 1 · 14 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215272-001 10426743 2036-05-19 U-2625 2022-06-21 N215272-001 10426743 2036-05-19 U-4048 2022-06-21 N215272-001 11458108 2036-05-19 Drug product 2022-10-07 N215272-001 11612573 2036-05-19 U-2625 2023-04-20 N215272-001 11612573 2036-05-19 U-4048 2023-04-20 N215272-001 11617724 2036-05-19 Drug product 2023-04-20 N215272-001 11622945 2036-05-19 Drug product 2023-04-20 N215272-001 10195160 2036-05-23 Drug product 2022-06-21 N215272-001 10647649 2038-11-13 Drug substance 2022-06-21 N215272-001 11597692 2038-11-13 Drug substance, Drug product 2023-03-31 N215272-001 11497718 2039-11-13 U-4048 2025-01-10 N215272-001 11590088 2039-11-13 U-2625 2023-03-16 N215272-001 11938099 2039-11-13 U-4048 2025-01-10 N215272-001 12569453 2039-12-18 U-4048 2026-04-06
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215272-001 NCE 2027-05-23 N215272-001 I-956 2027-12-12
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 2026-02-19 14:30 UTC 2026-02 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215272-001 VTAMA 1% CREAM / TOPICAL RLD, RS 2022-05-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 7 · 247 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 N215272-001 10195160 2036-05-19 Drug product 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 10426743 2036-05-19 U-4048 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 10426743 2036-05-19 U-2625 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11458108 2036-05-19 Drug product 2022-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11612573 2036-05-19 U-4048 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11612573 2036-05-19 U-2625 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11617724 2036-05-19 Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11622945 2036-05-19 Drug product 2023-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 10647649 2038-11-13 Drug substance 2022-06-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11597692 2038-11-13 Drug substance, Drug product 2023-03-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11497718 2039-11-13 U-4048 2025-01-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11590088 2039-11-13 U-2625 2023-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215272-001 11938099 2039-11-13 U-4048 2025-01-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 10195160 2036-05-19 Drug product 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 10426743 2036-05-19 U-4048 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 10426743 2036-05-19 U-2625 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11458108 2036-05-19 Drug product 2022-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11612573 2036-05-19 U-4048 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11612573 2036-05-19 U-2625 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11617724 2036-05-19 Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11622945 2036-05-19 Drug product 2023-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 10647649 2038-11-13 Drug substance 2022-06-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11597692 2038-11-13 Drug substance, Drug product 2023-03-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11497718 2039-11-13 U-4048 2025-01-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11590088 2039-11-13 U-2625 2023-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215272-001 11938099 2039-11-13 U-4048 2025-01-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215272-001 10195160 2036-05-19 Drug product 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 10426743 2036-05-19 U-4048 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 10426743 2036-05-19 U-2625 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11458108 2036-05-19 Drug product 2022-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11612573 2036-05-19 U-4048 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11612573 2036-05-19 U-2625 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11617724 2036-05-19 Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11622945 2036-05-19 Drug product 2023-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 10647649 2038-11-13 Drug substance 2022-06-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11597692 2038-11-13 Drug substance, Drug product 2023-03-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11497718 2039-11-13 U-4048 2025-01-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11590088 2039-11-13 U-2625 2023-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215272-001 11938099 2039-11-13 U-4048 2025-01-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215272-001 10195160 2036-05-19 Drug product 2022-06-21 fd3edfee7708…
Observed Orange Book exclusivity history# Additional Listing Data#
Finished product Yes
Brand name base VTAMA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAPINAROF 10 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 84HW7D0V04 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2602301 Internal RxNorm lookup 2602306 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 81672-5051-1 VTAMA 60 g in 1 TUBE CREAM 60 4 81672-5051-1 VTAMA 1 in 1 PACKAGE CREAM 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81672-5051 VTAMA (TAPINAROF) CREAM [DERMAVANT SCIENCES, INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241215_9309d20f-8cd4-4c96-93fa-7f730e83c7ab.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 81672-5051-1 81672505101 1 TUBE in 1 PACKAGE (81672-5051-1) / 60 g in 1 TUBE 1 tube 2025-05-28 0000-00-00 No No Current