Venlafaxine Hydrochloride

Product NDC
43353-689
11-digit product format
433530689
Labeler code
43353
Product ID
43353-689_a9d8d871-3b80-47a6-9029-1e9445bcdf77
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA090027
Marketing category
ANDA
Marketing start
2010-08-04
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 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
2019-12-31
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 productproduct43353-689IInactivated by FDA2026-10-05
excluded packagepackage43353-68943353-689-53IInactivated by FDA2026-10-05

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 · 42 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 packagepackage43353-689-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43353-689-53f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43353-689-532ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43353-689-53a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43353-689-53cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43353-689-53cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43353-689-53302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43353-689-53ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43353-689-530efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43353-689-53ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43353-689-53367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43353-689-53557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43353-689-538af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43353-689-53834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43353-689-531332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43353-689-53fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43353-689-5386f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43353-689-53bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43353-689-538dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43353-689-53e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43353-689-539bebd1f3094a…5416666fcb17…

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
A090027-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-04
A090027-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-04
A090027-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-04
A090027-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-04
A090027-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-04

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 22:38:342026-08A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-0484e616aacf4f…
2026-09-14 22:38:342026-08A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-0484e616aacf4f…
2026-08-18 06:07:402026-07A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-04caaa826d4ba7…
2026-08-18 06:07:402026-07A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-04011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-0431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-0431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-046a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-046a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-04fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-04fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-04b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-04b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090027-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090027-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090027-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090027-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-08-0403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090027-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-08-0403ed91905a0d…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-09-15 20:21 UTC2019-09A090027-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090027-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090027-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090027-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A090027-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090027-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090027-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090027-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090027-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A090027-005AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-689-532020-01-31C16284748780-19d75b9d0-232c-f424-e053-dadaa90a57ceVENLAFAXINE HYDROCHLORIDE TABLETS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-689-53Venlafaxine Hydrochloride60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-689-53EA - Each43353-6897ca6d254-5bbf-44e1-b5cc-d97561b6428d12014-06-03

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-689VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 1 package rows20140513_f1f123a3-d52b-4d27-aba2-db315565be80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSNf1f123a3-d52b-4d27-aba2-db315565be801
313586venlafaxine HCl 75 MG Oral TabletPSNf1f123a3-d52b-4d27-aba2-db315565be801
313584venlafaxine 37.5 MG Oral TabletSCDf1f123a3-d52b-4d27-aba2-db315565be801
313586venlafaxine 75 MG Oral TabletSCDf1f123a3-d52b-4d27-aba2-db315565be801
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYf1f123a3-d52b-4d27-aba2-db315565be801
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSYf1f123a3-d52b-4d27-aba2-db315565be801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-689-534335306895360 in 1 BOTTLE, PLASTICHistorical