Home NDC 0006-5331 WELIREG
Product NDC 0006-5331
11-digit product format 000065331
Labeler code 0006
Product ID 0006-5331_114cd6ad-9203-4034-b390-3e0901e064a4
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name belzutifan
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA215383
Marketing category NDA
Marketing start 2021-08-13
Substance BELZUTIFAN
Active strength 40 mg/1
Pharmacologic classes Cytochrome P450 3A4 Inducers [MoA], Hypoxia-inducible Factor 2 alpha Inhibitors [MoA], Hypoxia-inducible Factor Inhibitor [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 42 .
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 N215383-001 WELIREG BELZUTIFAN 40MG TABLET / ORAL RLD, RS 2021-08-13
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 N215383-001 12358870 2042-06-30 Drug product 2025-07-24
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 5 matching rows.
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 2026-08-18 06:07:40 2026-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N215383-001 WELIREG 40MG TABLET / ORAL RLD, RS 2021-08-13 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 122 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 9908845 2034-09-05 U-4565 Drug substance, Drug product 2021-09-09 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 RE49948 2034-09-05 U-4565 Drug substance, Drug product 2024-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 10335388 2036-04-14 U-4565 2026-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N215383-001 9908845 2034-09-05 U-4195 Drug substance, Drug product 2021-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 9908845 2034-09-05 U-4176 Drug substance, Drug product 2021-09-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 RE49948 2034-09-05 U-4195 Drug substance, Drug product 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 RE49948 2034-09-05 U-4176 Drug substance, Drug product 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N215383-001 12358870 2042-06-30 Drug product 2025-07-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 9908845 2034-09-05 U-3780 Drug substance, Drug product 2021-09-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N215383-001 RE49948 2034-09-05 U-3780 Drug substance, Drug product 2024-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 9908845 2034-09-05 U-3780 Drug substance, Drug product 2021-09-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 RE49948 2034-09-05 U-3201 Drug substance, Drug product 2024-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N215383-001 RE49948 2034-09-05 U-3780 Drug substance, Drug product 2024-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N215383-001 9908845 2034-09-05 U-3201 Drug substance, Drug product 2021-09-09 03ed91905a0d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 91 observed states.
Additional Listing Data#
Finished product Yes
Brand name base WELIREG
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength BELZUTIFAN 40 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7K28NB895L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2567231 Internal RxNorm lookup 2567237 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 0006-5331-01 WELIREG 90 in 1 BOTTLE TABLET, FILM COATED 90 11 0006-5331-58 WELIREG 90 in 1 BOTTLE TABLET, FILM COATED 90 11 0006-5331-58 WELIREG 1 in 1 CARTON TABLET, FILM COATED 1 11 0006-5331-59 WELIREG 1 in 1 CARTON TABLET, FILM COATED 1 11 0006-5331-59 WELIREG 90 in 1 BOTTLE TABLET, FILM COATED 90 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-5331 WELIREG (BELZUTIFAN) TABLET, FILM COATED [MERCK SHARP & DOHME LLC] 11 Current NDC, Legacy NDC, 5 package rows 20250523_13e15ee0-d679-4fa9-9430-e2e2170474da.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join WELIREG BELZUTIFAN Merck Sharp & Dohme LLC 13e15ee0-d679-4fa9-9430-e2e2170474da 2026-06-12 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 215383 application number: NDA215383 ndc (product): 0006-5331
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 0006-5331-01 00006533101 90 TABLET, FILM COATED in 1 BOTTLE (0006-5331-01) 2021-08-13 0000-00-00 No No Current 0006-5331-58 00006533158 1 BOTTLE in 1 CARTON (0006-5331-58) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-06-21 Yes No Current 0006-5331-59 00006533159 1 BOTTLE in 1 CARTON (0006-5331-59) / 90 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2023-06-21 Yes No Current