Venlafaxine Hydrochloride

Product NDC
43353-798
11-digit product format
433530798
Labeler code
43353
Product ID
43353-798_ad3a32db-8ab9-402e-a263-33931bc29cd1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA079098
Marketing category
ANDA
Marketing start
2012-05-07
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct43353-798DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-17DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-53DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-60DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-70DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-80DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-84DDiscontinued by firm2026-10-05
excluded packagepackage43353-79843353-798-88DDiscontinued 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 · 16 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 packagepackage43353-798-84d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-798-80d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-798-53d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-798-17d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-798-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-798-88d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage43353-798-70d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-84f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-80f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-53f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-17f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-88f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-798-70f5e01cc5f278…a2eaf40c39c3…

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
43353-798-53EA - Each43353-79891811fe5-8790-41d8-bd64-f0b4c82bcde512014-06-03
43353-798-60EA - Each43353-798b03fcd89-0ad2-40d2-aa0f-3cc3dbc7bac612021-04-08
43353-798-70EA - Each43353-798e051629e-82de-40c7-b8a3-8cf9037db32712014-08-01
43353-798-80EA - Each43353-7984c3102cc-e7be-4f36-a782-0dc7f9b61c1b12014-06-03
43353-798-84EA - Each43353-7982de05842-e905-4f94-a4ea-201d8066b5ae12014-08-01
43353-798-88EA - Each43353-798e2e1585a-f2a0-466f-91e0-5ac68724625712014-06-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-798VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Legacy NDC20210323_4146cf6f-4181-49e1-9f59-3ba280f60ced.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-798-17433530798176030 TABLET in 1 BOTTLE, PLASTIC (43353-798-17) 6030 tablet2014-11-210000-00-00NoNoCurrent
43353-798-534335307985360 TABLET in 1 BOTTLE, PLASTIC (43353-798-53) 60 tablet2013-01-230000-00-00NoNoCurrent
43353-798-604335307986090 TABLET in 1 BOTTLE, PLASTIC (43353-798-60) 90 tablet2021-02-090000-00-00NoNoCurrent
43353-798-7043353079870120 TABLET in 1 BOTTLE, PLASTIC (43353-798-70) 120 tablet2013-11-130000-00-00NoNoCurrent
43353-798-8043353079880180 TABLET in 1 BOTTLE, PLASTIC (43353-798-80) 180 tablet2013-01-230000-00-00NoNoCurrent
43353-798-84433530798841100 TABLET in 1 BOTTLE, PLASTIC (43353-798-84) 1100 tablet2014-11-210000-00-00NoNoCurrent
43353-798-8843353079888900 TABLET in 1 BOTTLE, PLASTIC (43353-798-88) 900 tablet2012-08-240000-00-00NoNoCurrent