Venlafaxine Hydrochloride

Product NDC
70518-2587
11-digit product format
705182587
Labeler code
70518
Product ID
70518-2587_d6a99790-b676-7b9d-e053-2995a90a6b9a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
NDA022104
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-02-18
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 productproduct70518-2587DDiscontinued by firm2026-08-10
excluded packagepackage70518-258770518-2587-0DDiscontinued by firm2026-08-10
excluded packagepackage70518-258770518-2587-1DDiscontinued by firm2026-08-10

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 · 13 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 packagepackage70518-2587-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-2587-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-2587-02ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-2587-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-2587-0cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-2587-0cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-2587-0302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-2587-0ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-2587-00efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-2587-0ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage70518-2587-0367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage70518-2587-0557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022104-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20
N022104-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20
N022104-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20
N022104-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
N022104-001AB
N022104-002AB
N022104-003AB
N022104-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N022104-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022104-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022104-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022104-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022104-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022104-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022104-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022104-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022104-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022104-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022104-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022104-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022104-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022104-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022104-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022104-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022104-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022104-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N022104-004AB1d06236e962d9…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2587VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]7Legacy NDC20250322_fd4eaf3f-ef9c-4615-9438-a95d91feee06.zip

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETrigen Laboratories, LLCfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c972025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022104
application number: NDA022104
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022104
application number: NDA022104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2587-07051825870090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2587-0) 2020-02-180000-00-00NoNoCurrent