Home NDC 0006-0568-40 ZOLINZA
Product NDC 0006-0568
Requested package NDC 0006-0568-40
11-digit product format 000060568
Labeler code 0006
Product ID 0006-0568_27d99e44-bbc6-445d-b08b-e32fd8702dc3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name vorinostat
Dosage form CAPSULE
Route ORAL
Labeler Merck Sharp & Dohme LLC
Application NDA021991
Marketing category NDA
Marketing start 2006-10-06
Substance VORINOSTAT
Active strength 100 mg/1
Pharmacologic classes Histone Deacetylase Inhibitor [EPC], Histone Deacetylase Inhibitors [MoA]
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 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 N021991-001 ZOLINZA VORINOSTAT 100MG CAPSULE / ORAL RLD, RS 2006-10-06
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N021991-001 8093295 2026-05-16 Drug product N021991-001 7456219 2027-03-11 Drug substance N021991-001 8450372 2028-03-18 U-892 2013-06-14
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 2026-08-01 22:54:32 2026-06 N021991-001 ZOLINZA 100MG CAPSULE / ORAL RLD, RS 2006-10-06 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 2026-08-01 22:54:32 2026-06 N021991-001 8093295 2026-05-16 Drug product a50c72e98297…2026-08-01 22:54:32 2026-06 N021991-001 7456219 2027-03-11 Drug substance a50c72e98297…2026-08-01 22:54:32 2026-06 N021991-001 8450372 2028-03-18 U-892 2013-06-14 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Additional Listing Data#
Finished product Yes
Brand name base ZOLINZA
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VORINOSTAT 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 58IFB293JI Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 668579 Internal RxNorm lookup 668606 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 0006-0568-40 ZOLINZA 120 in 1 BOTTLE CAPSULE 120 27
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0006-0568 ZOLINZA (VORINOSTAT) CAPSULE [MERCK SHARP & DOHME LLC] 26 Current NDC, Legacy NDC, 1 package rows 20241129_cd86ee78-2781-468b-930c-3c4677bcc092.zip
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 0006-0568-40 00006056840 120 CAPSULE in 1 BOTTLE (0006-0568-40) 120 capsule 2006-10-06 0000-00-00 No No Current