Home NDC 0003-5710-21 ZENBEXUS
Product NDC 0003-5710
Requested package NDC 0003-5710-21
11-digit product format 000035710
Labeler code 0003
Product ID 0003-5710_05b6e27f-40ba-4939-a0c3-8e8ae1feae98
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name iberdomide
Dosage form CAPSULE
Route ORAL
Labeler E.R. Squibb & Sons, L.L.C.
Application NDA221075
Marketing category NDA
Marketing start 2026-08-13
Substance IBERDOMIDE HYDROCHLORIDE
Active strength 1 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 N221075-001 ZENBEXUS IBERDOMIDE HYDROCHLORIDE EQ 0.75MG BASE CAPSULE / ORAL RLD 2026-08-13 N221075-002 ZENBEXUS IBERDOMIDE HYDROCHLORIDE EQ 1MG BASE CAPSULE / ORAL RLD, RS 2026-08-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N221075-001 NCE 2031-08-13 N221075-002 NCE 2031-08-13
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 N221075-001 ZENBEXUS EQ 0.75MG BASE CAPSULE / ORAL RLD 2026-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N221075-002 ZENBEXUS EQ 1MG BASE CAPSULE / ORAL RLD, RS 2026-08-13 84e616aacf4f…
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 N221075-001 NCE 2031-08-13 84e616aacf4f…2026-09-14 22:38:34 2026-08 N221075-002 NCE 2031-08-13 84e616aacf4f…
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 ZENBEXUS
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength IBERDOMIDE HYDROCHLORIDE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 79L3645KFI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 4 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2749737 Internal RxNorm lookup 2749743 Internal RxNorm lookup 2749745 Internal RxNorm lookup 2749747 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 · 1 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 0003-5710-21 00003571021 21 CAPSULE in 1 BOTTLE (0003-5710-21) 21 capsule 2026-08-13 No No Current