Venlafaxine Hydrochloride

Product NDC
50268-819
11-digit product format
502680819
Labeler code
50268
Product ID
50268-819_ed873130-8230-1fc9-e053-2a95a90a64dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
AvPAK
Application
ANDA203332
Marketing category
ANDA
Marketing start
2021-04-27
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-819DDiscontinued by firm2026-08-03
excluded packagepackage50268-81950268-819-15DDiscontinued by firm2026-08-03

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50268-819-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50268-819-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50268-819-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50268-819-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50268-819-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50268-819-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50268-819-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50268-819-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50268-819-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50268-819-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50268-819-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50268-819-15557ba5c1ecfa…9c80585c8c6e…

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
A203332-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12
A203332-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12
A203332-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203332-001AB
A203332-002AB
A203332-003AB

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 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12d06236e962d9…
2024-10-29 15:01 UTC2024-10A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203332-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203332-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203332-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2020-03-128072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A203332-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203332-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203332-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203332-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203332-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203332-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203332-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203332-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203332-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203332-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203332-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203332-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203332-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203332-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203332-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203332-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203332-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203332-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203332-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203332-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203332-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203332-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203332-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203332-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203332-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203332-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203332-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203332-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203332-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203332-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203332-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203332-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203332-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203332-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203332-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203332-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203332-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203332-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203332-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203332-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-819-11EA - Each50268-819a641bff6-9a6d-40a2-b069-0ecfdf6462f412021-06-02
50268-819-15EA - Each50268-81947169001-0ada-4edc-9df7-df40cb7a46a112021-06-02

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
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAdvagen Pharma Ltd.48a75840-64e4-4d44-9a62-0093730031052024-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203332
application number: ANDA203332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-819-155026808191550 BLISTER PACK in 1 BOX (50268-819-15) > 1 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (50268-819-11) 50 blister pack2021-04-270000-00-00NoNoCurrent