Venlafaxine Hydrochloride

Product NDC
50268-801
11-digit product format
502680801
Labeler code
50268
Product ID
50268-801_d5e0a7e8-d026-d2cf-e053-2995a90a4d7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA079098
Marketing category
ANDA
Marketing start
2016-06-06
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50268-801DDiscontinued by firm2026-10-05
excluded packagepackage50268-80150268-801-13DDiscontinued by firm2026-10-05
excluded packagepackage50268-80150268-801-15DDiscontinued by firm2026-10-05

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 · 36 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 packagepackage50268-801-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50268-801-15d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50268-801-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50268-801-15f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50268-801-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50268-801-152ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50268-801-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50268-801-15a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50268-801-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50268-801-15cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50268-801-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50268-801-15cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50268-801-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50268-801-15302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50268-801-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50268-801-15ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50268-801-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50268-801-150efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50268-801-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50268-801-15ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50268-801-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50268-801-15367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50268-801-13557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50268-801-15557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A079098-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11
A079098-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11
A079098-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11
A079098-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11
A079098-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11

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 6 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-08-18 06:07:402026-07A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-1103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079098-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079098-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079098-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079098-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079098-005AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079098-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079098-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079098-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079098-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A079098-005AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079098-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079098-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079098-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079098-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079098-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079098-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079098-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079098-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079098-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A079098-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079098-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079098-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079098-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079098-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A079098-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079098-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079098-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079098-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079098-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A079098-005AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079098-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079098-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079098-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079098-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A079098-005AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079098-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079098-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079098-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079098-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A079098-005AB1782e0a99824c…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-801-11EA - Each50268-801fee24319-6125-4ae2-811c-3edced75074712016-07-19
50268-801-13EA - Each50268-8016a583f2e-4fff-440f-97c4-3656e924509212019-03-12
50268-801-15EA - Each50268-8010c02c768-ecf5-43f5-9b07-3c240dba9a0b12016-07-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-801-135026808011330 BLISTER PACK in 1 BOX (50268-801-13) > 1 TABLET in 1 BLISTER PACK (50268-801-11) 30 blister pack2019-02-050000-00-00NoNoCurrent