Home NDC 74695-823-18 VIVJOA
Product NDC 74695-823
Requested package NDC 74695-823-18
11-digit product format 746950823
Labeler code 74695
Product ID 74695-823_47e259e7-fa6d-849f-e063-6294a90aeba7
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name oteseconazole
Dosage form CAPSULE
Route ORAL
Labeler Mycovia Pharmaceuticals, Inc.
Application NDA215888
Marketing category NDA
Marketing start 2022-07-11
Substance OTESECONAZOLE
Active strength 150 mg/1
Pharmacologic classes Azole Antifungal [EPC], Azoles [CS], Breast Cancer Resistance Protein 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 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 N215888-001 VIVJOA OTESECONAZOLE 150MG CAPSULE / ORAL RLD, RS 2022-04-26
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N215888-001 NCE 2027-04-26 N215888-001 GAIN 2032-04-26
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 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215888-001 VIVJOA 150MG CAPSULE / ORAL RLD, RS 2022-04-26 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 145 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 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 8236962 2031-04-22 Drug substance, Drug product 2022-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 8754227 2031-04-22 U-3366 2022-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 11247981 2033-05-09 U-3366 2022-05-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 10414751 2036-03-17 Drug substance, Drug product 2022-05-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215888-001 9840492 2036-03-17 Drug substance, Drug product 2022-05-25 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 58 observed states.
Additional Listing Data#
Finished product Yes
Brand name base VIVJOA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength OTESECONAZOLE 150 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VHH774W97N Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2602582 Internal RxNorm lookup 2602588 Internal RxNorm lookup 2605802 Internal RxNorm lookup 2605803 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 74695-823-18 VIVJOA 1 in 1 CARTON CAPSULE 1 5 74695-823-18 VIVJOA 1 in 1 CONTAINER CAPSULE 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 74695-823 VIVJOA (OTESECONAZOLE) CAPSULE [MYCOVIA PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20240704_e21d5008-800e-4417-927f-14340341865f.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 74695-823-18 74695082318 1 CONTAINER in 1 CARTON (74695-823-18) / 1 BLISTER PACK in 1 CONTAINER / 18 CAPSULE in 1 BLISTER PACK 1 container 2022-07-11 0000-00-00 No No Current