Venlafaxine

Product NDC
68084-905
11-digit product format
680840905
Labeler code
68084
Product ID
68084-905_5fc2700c-2c69-5b96-e053-2a91aa0ac524
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
American Health Packaging
Application
ANDA077653
Marketing category
ANDA
Marketing start
2015-10-19
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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 productproduct68084-905DDiscontinued by firm2026-08-03
excluded packagepackage68084-90568084-905-25DDiscontinued 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 packagepackage68084-905-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68084-905-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68084-905-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68084-905-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68084-905-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68084-905-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68084-905-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68084-905-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68084-905-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage68084-905-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage68084-905-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage68084-905-25557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A077653-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13
A077653-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13
A077653-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13
A077653-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13
A077653-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077653-001AB
A077653-002AB
A077653-003AB
A077653-004AB
A077653-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2008-06-135bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A077653-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077653-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077653-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077653-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077653-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077653-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077653-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077653-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077653-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077653-005AB15bbf6a4d5a75…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-905-25EA - Each68084-905791e076d-d33d-4fe3-8eff-9bcaa46e946d12015-12-02
68084-905-95EA - Each68084-90580756117-7c1c-4ef9-a95e-f0c20df0c9a512015-12-02

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VenlafaxineVENLAFAXINESt. Mary's Medical Park Pharmacyfab65158-b2f7-1db7-e053-6294a90af2312026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepackd4638a83-2720-430c-b529-c852aa2f73662025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fa1db21b-98b8-3bde-e053-6394a90aa6382025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEA-S Medication Solutions7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a2025-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.017a84aa-0e1f-f560-e063-6294a90a90692025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fe7de51e-8a81-fe68-e053-6294a90a73392025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepack185d90ab-1ba4-dd59-0565-e35f0fd39a2d2024-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited51334651-7a7f-4653-bf9d-d5be04fd902d2024-08-14Exact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEAmerican Health Packagingd8899628-6e1b-40c6-9bc8-553d91ae2d0c2024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBryant Ranch Prepack1471508e-7fe4-43db-94ea-b4df1bcbafa92024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEBluePoint Laboratories172b3d3d-bdae-47bf-8fba-edd6da1a86492023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.72efad5f-0909-46a5-aa13-ac24fe015fe62023-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEA-S Medication Solutionsd3475ce0-1368-4961-a9b9-44c5c33cdc582023-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653
VenlafaxineVENLAFAXINEProficient Rx LPb5fc0187-590c-4bb9-a910-821eb0dc1fc82021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077653
application number: ANDA077653