Home NDC 71332-008-30 VEPPANU
Product NDC 71332-008
Requested package NDC 71332-008-30
11-digit product format 713320008
Labeler code 71332
Product ID 71332-008_3e8ae2a7-cbca-4a8c-86d8-41892cd03b2d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vepdegestrant
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rigel Pharmaceuticals, Inc.
Application NDA219835
Marketing category NDA
Marketing start 2026-06-16
Substance VEPDEGESTRANT
Active strength 200 mg/1
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 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N219835-001 VEPPANU VEPDEGESTRANT 100MG TABLET / ORAL RLD 2026-05-01 N219835-002 VEPPANU VEPDEGESTRANT 200MG TABLET / ORAL RLD, RS 2026-05-01
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 N219835-001 10899742 2037-12-01 U-4278 2026-05-29 N219835-001 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 N219835-001 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 N219835-002 10899742 2037-12-01 U-4278 2026-05-29 N219835-002 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 N219835-002 10647698 2038-01-30 Drug substance, Drug product 2026-05-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N219835-001 NCE 2031-05-01 N219835-002 NCE 2031-05-01
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 N219835-001 VEPPANU 100MG TABLET / ORAL RLD 2026-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-002 VEPPANU 200MG TABLET / ORAL RLD, RS 2026-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219835-001 VEPPANU 100MG TABLET / ORAL RLD 2026-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-002 VEPPANU 200MG TABLET / ORAL RLD, RS 2026-05-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-001 VEPPANU 100MG TABLET / ORAL RLD 2026-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-002 VEPPANU 200MG TABLET / ORAL RLD, RS 2026-05-01 a50c72e98297…
Observed Orange Book patent history# 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 N219835-001 10899742 2037-12-01 U-4278 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-001 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-001 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-002 10899742 2037-12-01 U-4278 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-002 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-002 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219835-001 10899742 2037-12-01 U-4278 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-001 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-001 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-002 10899742 2037-12-01 U-4278 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-002 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-002 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-001 10899742 2037-12-01 U-4278 2026-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-001 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-001 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-002 10899742 2037-12-01 U-4278 2026-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-002 11597720 2037-12-01 U-4278 Drug substance, Drug product 2026-05-29 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-002 10647698 2038-01-30 Drug substance, Drug product 2026-05-29 a50c72e98297…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2026-09-14 22:38:34 2026-08 N219835-001 NCE 2031-05-01 84e616aacf4f…2026-09-14 22:38:34 2026-08 N219835-002 NCE 2031-05-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 N219835-001 NCE 2031-05-01 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N219835-002 NCE 2031-05-01 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-001 NCE 2031-05-01 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N219835-002 NCE 2031-05-01 a50c72e98297…
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 VEPPANU
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VEPDEGESTRANT 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WC1U3R1YMI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2743355 Internal RxNorm lookup 2743361 Internal RxNorm lookup 2743363 Internal RxNorm lookup 2743365 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 · 2 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 71332-008-30 71332000830 30 TABLET, FILM COATED in 1 BOTTLE (71332-008-30) 2026-06-16 No No Current