Home NDC 73336-075-90 GEMTESA
Product NDC 73336-075
Requested package NDC 73336-075-90
11-digit product format 733360075
Labeler code 73336
Product ID 73336-075_6744a1cf-7abb-4623-85e3-8f67a9eb19d4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vibegron
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sumitomo Pharma America, Inc.
Application NDA213006
Marketing category NDA
Marketing start 2020-12-29
Substance VIBEGRON
Active strength 75 mg/1
Pharmacologic classes Adrenergic beta3-Agonists [MoA], beta3-Adrenergic Agonist [EPC]
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 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 N213006-001 GEMTESA VIBEGRON 75MG TABLET / ORAL RLD, RS 2020-12-23
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 N213006-001 12357636 2042-07-06 U-4219 2025-07-30
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N213006-001 I-955 2027-12-18
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 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N213006-001 GEMTESA 75MG TABLET / ORAL RLD, RS 2020-12-23 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 105 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 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N213006-001 12357636 2042-07-06 U-4219 2025-07-30 84e616aacf4f…2026-08-18 06:07:40 2026-07 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N213006-001 12357636 2042-07-06 U-4219 2025-07-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N213006-001 12357636 2042-07-06 U-4219 2025-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 8247415 2034-12-23 U-4219 Drug substance, Drug product 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 8247415 2034-12-23 U-3045 Drug substance, Drug product 2021-01-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N213006-001 12357636 2042-05-04 U-4219 2025-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N213006-001 12357636 2042-05-04 U-4219 2025-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 12180219 2034-03-12 Drug substance, Drug product 2025-01-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 8653260 2029-04-02 Drug substance 2021-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 8247415 2030-12-01 U-3045 Drug substance, Drug product 2021-01-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N213006-001 12102638 2040-03-22 U-3045 2024-10-07 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 41 observed states.
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 GEMTESA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VIBEGRON 75 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination M5TSE03W5U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2472315 Internal RxNorm lookup 2472321 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 73336-075-07 GEMTESA 1 in 1 CARTON TABLET, FILM COATED 1 12 73336-075-07 GEMTESA 7 in 1 BOTTLE TABLET, FILM COATED 7 12 73336-075-30 GEMTESA 30 in 1 BOTTLE TABLET, FILM COATED 30 12 73336-075-90 GEMTESA 90 in 1 BOTTLE TABLET, FILM COATED 90 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 73336-075 GEMTESA (VIBEGRON) TABLET, FILM COATED [SUMITOMO PHARMA AMERICA, INC.
] 12 Current NDC, Legacy NDC, 4 package rows 20250409_25f21d25-14f8-4fda-91f6-7aa8b68aa1c8.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 Marketing start Marketing end Sample Exclude flag Status 73336-075-90 73336007590 90 TABLET, FILM COATED in 1 BOTTLE (73336-075-90) 2020-12-29 0000-00-00 No No Current