Venclexta

Product NDC
0074-0576
11-digit product format
000740576
Labeler code
0074
Product ID
0074-0576_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
100 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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0074-05760074-0576-34DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208573-001VENCLEXTAVENETOCLAX10MGTABLET / ORALABRLD2016-04-11
N208573-002VENCLEXTAVENETOCLAX50MGTABLET / ORALABRLD2016-04-11
N208573-003VENCLEXTAVENETOCLAX100MGTABLET / ORALABRLD, RS2016-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N208573-001AB
N208573-002AB
N208573-003AB

Orange Book patents#

Current patent rows page 1 of 1 · 42 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208573-00191749822030-05-26U-23232016-05-04
N208573-00191749822030-05-26U-24452016-05-04
N208573-00191749822030-05-26U-24462016-05-04
N208573-00191749822030-05-26U-25372016-05-04
N208573-00185463992031-06-27Drug substance, Drug product2016-05-04
N208573-001107308732031-11-21Drug substance2020-08-17
N208573-00187226572032-01-29Drug substance2020-02-13
N208573-001113695992032-05-23Drug product2022-07-20
N208573-001109939422033-09-06U-31142021-05-24
N208573-001111100872033-09-06U-32222021-10-07
N208573-001111100872033-09-06U-32232021-10-07
N208573-001114132822033-09-06U-34122022-09-12
N208573-001115901282033-09-06U-35482023-03-24
N208573-00195392512033-09-06U-25382019-06-13
N208573-00291749822030-05-26U-23232016-05-04
N208573-00291749822030-05-26U-24452016-05-04
N208573-00291749822030-05-26U-24462016-05-04
N208573-00291749822030-05-26U-25372016-05-04
N208573-00285463992031-06-27Drug substance, Drug product2016-05-04
N208573-002107308732031-11-21Drug substance2020-08-17
N208573-00287226572032-01-29Drug substance2020-02-13
N208573-002113695992032-05-23Drug product2022-07-20
N208573-002109939422033-09-06U-31142021-05-24
N208573-002111100872033-09-06U-32222021-10-07
N208573-002111100872033-09-06U-32232021-10-07
N208573-002114132822033-09-06U-34122022-09-12
N208573-002115901282033-09-06U-35482023-03-24
N208573-00295392512033-09-06U-25382019-06-13
N208573-00391749822030-05-26U-23232016-05-04
N208573-00391749822030-05-26U-24452016-05-04
N208573-00391749822030-05-26U-24462016-05-04
N208573-00391749822030-05-26U-25372016-05-04
N208573-00385463992031-06-27Drug substance, Drug product2016-05-04
N208573-003107308732031-11-21Drug substance2020-08-17
N208573-00387226572032-01-29Drug substance2020-02-13
N208573-003113695992032-05-23Drug product2022-07-20
N208573-003109939422033-09-06U-31142021-05-24
N208573-003111100872033-09-06U-32222021-10-07
N208573-003111100872033-09-06U-32232021-10-07
N208573-003114132822033-09-06U-34122022-09-12
N208573-003115901282033-09-06U-35482023-03-24
N208573-00395392512033-09-06U-25382019-06-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N208573-001ODE-2392026-05-15
N208573-002ODE-2392026-05-15
N208573-003ODE-2392026-05-15

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-11d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-11d06236e962d9…
2024-10-29 15:01 UTC2024-10N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-1179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-11301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208573-002VENCLEXTA50MGTABLET / ORALRLD2016-04-111e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208573-003VENCLEXTA100MGTABLET / ORALRLD, RS2016-04-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208573-001VENCLEXTA10MGTABLET / ORALRLD2016-04-118072bd15b7f6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208573-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208573-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208573-003AB1a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 38 · 1,494 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N208573-00191749822030-05-26U-25372016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00191749822030-05-26U-24452016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00191749822030-05-26U-23232016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00191749822030-05-26U-24462016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00185463992031-06-27Drug substance, Drug product2016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001107308732031-11-21Drug substance2020-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00187226572032-01-29Drug substance2020-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001113695992032-05-23Drug product2022-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001109939422033-09-06U-31142021-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001111100872033-09-06U-32222021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001111100872033-09-06U-32232021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001114132822033-09-06U-34122022-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-001115901282033-09-06U-35482023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00195392512033-09-06U-25382019-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00291749822030-05-26U-23232016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00291749822030-05-26U-25372016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00291749822030-05-26U-24462016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00291749822030-05-26U-24452016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00285463992031-06-27Drug substance, Drug product2016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002107308732031-11-21Drug substance2020-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00287226572032-01-29Drug substance2020-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002113695992032-05-23Drug product2022-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002109939422033-09-06U-31142021-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002111100872033-09-06U-32222021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002111100872033-09-06U-32232021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002114132822033-09-06U-34122022-09-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002115901282033-09-06U-35482023-03-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00295392512033-09-06U-25382019-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00391749822030-05-26U-25372016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00391749822030-05-26U-24452016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00391749822030-05-26U-24462016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00391749822030-05-26U-23232016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00385463992031-06-27Drug substance, Drug product2016-05-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003107308732031-11-21Drug substance2020-08-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-00387226572032-01-29Drug substance2020-02-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003113695992032-05-23Drug product2022-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003109939422033-09-06U-31142021-05-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003111100872033-09-06U-32222021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003111100872033-09-06U-32232021-10-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003114132822033-09-06U-34122022-09-12011fe1cb6892…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 17 · 648 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-02-19 14:30 UTC2026-02N208573-001ODE-2392026-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-002ODE-2392026-05-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208573-003ODE-2392026-05-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-001ODE-1852025-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-001ODE-2112025-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-001ODE-2392026-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-002ODE-1852025-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-002ODE-2112025-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-002ODE-2392026-05-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-003ODE-1852025-06-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-003ODE-2112025-11-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208573-003ODE-2392026-05-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208573-001ODE-1852025-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-001ODE-2112025-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-001ODE-2392026-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-002ODE-1852025-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-002ODE-2112025-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-002ODE-2392026-05-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-003ODE-1852025-06-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-003ODE-2112025-11-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208573-003ODE-2392026-05-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-001ODE-1852025-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-001ODE-2112025-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-001ODE-2392026-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-002ODE-1852025-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-002ODE-2112025-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-002ODE-2392026-05-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-003ODE-1852025-06-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-003ODE-2112025-11-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208573-003ODE-2392026-05-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-001ODE-1852025-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-001ODE-2112025-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-001ODE-2392026-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-002ODE-1852025-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-002ODE-2112025-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-002ODE-2392026-05-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-003ODE-1852025-06-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-003ODE-2112025-11-21b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208573-003ODE-2392026-05-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208573-001ODE-1852025-06-0803ed91905a0d…

Additional Listing Data#

Finished product
Yes
Brand name base
Venclexta
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENETOCLAX100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
N54AIC43PWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1747561Internal RxNorm lookup
1747567Internal RxNorm lookup
1747572Internal RxNorm lookup
1747574Internal RxNorm lookup
1747575Internal RxNorm lookup
1747577Internal RxNorm lookup
1747579Internal RxNorm lookup
1747580Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b118a40d-6b56-cee3-10f6-ded821a97018Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fa4e04f-da16-456f-8bf8-e9049bbf45c3Product name220180806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0074-0576-11Venclexta1 in 1 BLISTER PACKTABLET, FILM COATED1282
0074-0576-11Venclexta1 in 1 CARTONTABLET, FILM COATED1282
0074-0576-22Venclexta120 in 1 BOTTLETABLET, FILM COATED120282
0074-0576-30Venclexta1 in 1 CARTONTABLET, FILM COATED1282
0074-0576-30Venclexta28 in 1 BOTTLETABLET, FILM COATED28282
0074-0576-34Venclexta180 in 1 BOTTLETABLET, FILM COATED180282
0074-0576-34Venclexta1 in 1 CARTONTABLET, FILM COATED1282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0074-0576-11EA - Each0074-057636cba366-1ddc-4a37-a224-6d747d7d419412016-05-16
0074-0576-22EA - Each0074-0576c0dbf3c2-1418-42b7-b78d-f8b84bd51d8012016-05-16
0074-0576-30EA - Each0074-0576e25ea65d-3e97-48a5-ae2d-ffc888fbfd6612022-10-06
0074-0576-34EA - Each0074-05768bf5bc05-a31d-4aa0-90f6-24616bc0c7a012018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0074-0576VENCLEXTA (VENETOCLAX) KIT VENCLEXTA (VENETOCLAX) TABLET, FILM COATED [ABBVIE INC.]276Current NDC, Legacy NDC, 7 package rows20240718_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenclextaVENETOCLAXAbbVie Inc.b118a40d-6b56-cee3-10f6-ded821a970182026-05-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 208573
application number: NDA208573
ndc (product): 0074-0576

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0074-0576-11000740576111 BLISTER PACK in 1 CARTON (0074-0576-11) / 1 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2016-04-110000-00-00NoNoCurrent
0074-0576-2200074057622120 TABLET, FILM COATED in 1 BOTTLE (0074-0576-22) 2016-04-110000-00-00NoNoCurrent
0074-0576-30000740576301 BOTTLE in 1 CARTON (0074-0576-30) / 28 TABLET, FILM COATED in 1 BOTTLE1 bottle2022-06-150000-00-00NoNoCurrent
0074-0576-34000740576341 BOTTLE in 1 CARTON (0074-0576-34) > 180 TABLET, FILM COATED in 1 BOTTLE1 bottle2018-11-210000-00-00NoNoCurrent