Home NDC 0074-0561 Venclexta
Product NDC 0074-0561
11-digit product format 000740561
Labeler code 0074
Product ID 0074-0561_17e6122b-5023-41a7-8b94-d2bdcee1a909
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Venetoclax
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AbbVie Inc.
Application NDA208573
Marketing category NDA
Marketing start 2016-04-11
Substance VENETOCLAX
Active strength 10 mg/1
Pharmacologic classes BCL-2 Inhibitor [EPC], Increased Cellular Death [PE], P-Glycoprotein Inhibitors [MoA]
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 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N208573-001 VENCLEXTA VENETOCLAX 10MG TABLET / ORAL AB RLD 2016-04-11 N208573-002 VENCLEXTA VENETOCLAX 50MG TABLET / ORAL AB RLD 2016-04-11 N208573-003 VENCLEXTA VENETOCLAX 100MG TABLET / ORAL AB RLD, RS 2016-04-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 42 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N208573-001 ODE-239 2026-05-15 N208573-002 ODE-239 2026-05-15 N208573-003 ODE-239 2026-05-15
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.
Product history page 1 of 4 · 123 observed 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 2026-02-19 14:30 UTC 2026-02 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208573-002 VENCLEXTA 50MG TABLET / ORAL RLD 2016-04-11 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N208573-003 VENCLEXTA 100MG TABLET / ORAL RLD, RS 2016-04-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N208573-001 VENCLEXTA 10MG TABLET / ORAL RLD 2016-04-11 8072bd15b7f6…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208573-001 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208573-002 AB 1 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N208573-003 AB 1 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 38 · 1,494 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N208573-001 9174982 2030-05-26 U-2537 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 9174982 2030-05-26 U-2445 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 9174982 2030-05-26 U-2323 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 9174982 2030-05-26 U-2446 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 8546399 2031-06-27 Drug substance, Drug product 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 10730873 2031-11-21 Drug substance 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 8722657 2032-01-29 Drug substance 2020-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 11369599 2032-05-23 Drug product 2022-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 10993942 2033-09-06 U-3114 2021-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 11110087 2033-09-06 U-3222 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 11110087 2033-09-06 U-3223 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 11413282 2033-09-06 U-3412 2022-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 11590128 2033-09-06 U-3548 2023-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-001 9539251 2033-09-06 U-2538 2019-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 9174982 2030-05-26 U-2323 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 9174982 2030-05-26 U-2537 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 9174982 2030-05-26 U-2446 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 9174982 2030-05-26 U-2445 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 8546399 2031-06-27 Drug substance, Drug product 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 10730873 2031-11-21 Drug substance 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 8722657 2032-01-29 Drug substance 2020-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 11369599 2032-05-23 Drug product 2022-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 10993942 2033-09-06 U-3114 2021-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 11110087 2033-09-06 U-3222 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 11110087 2033-09-06 U-3223 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 11413282 2033-09-06 U-3412 2022-09-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 11590128 2033-09-06 U-3548 2023-03-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-002 9539251 2033-09-06 U-2538 2019-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 9174982 2030-05-26 U-2537 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 9174982 2030-05-26 U-2445 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 9174982 2030-05-26 U-2446 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 9174982 2030-05-26 U-2323 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 8546399 2031-06-27 Drug substance, Drug product 2016-05-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 10730873 2031-11-21 Drug substance 2020-08-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 8722657 2032-01-29 Drug substance 2020-02-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 11369599 2032-05-23 Drug product 2022-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 10993942 2033-09-06 U-3114 2021-05-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 11110087 2033-09-06 U-3222 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 11110087 2033-09-06 U-3223 2021-10-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N208573-003 11413282 2033-09-06 U-3412 2022-09-12 011fe1cb6892…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 17 · 648 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Venclexta
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VENETOCLAX 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N54AIC43PW Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1747561 Internal RxNorm lookup 1747567 Internal RxNorm lookup 1747572 Internal RxNorm lookup 1747574 Internal RxNorm lookup 1747575 Internal RxNorm lookup 1747577 Internal RxNorm lookup 1747579 Internal RxNorm lookup 1747580 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 0074-0561-11 Venclexta 2 in 1 BLISTER PACK TABLET, FILM COATED 2 282 0074-0561-11 Venclexta 1 in 1 CARTON TABLET, FILM COATED 1 282 0074-0561-14 Venclexta 14 in 1 BLISTER PACK TABLET, FILM COATED 14 282 0074-0561-14 Venclexta 1 in 1 CARTON TABLET, FILM COATED 1 282
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0074-0561 VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.] 276 Current NDC, Legacy NDC, 4 package rows 20240718_b118a40d-6b56-cee3-10f6-ded821a97018.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0074-0561-11 00074056111 1 BLISTER PACK in 1 CARTON (0074-0561-11) / 2 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2016-04-11 0000-00-00 No No Current 0074-0561-14 00074056114 1 BLISTER PACK in 1 CARTON (0074-0561-14) / 14 TABLET, FILM COATED in 1 BLISTER PACK 1 blister pack 2016-04-11 0000-00-00 No No Current