VENLAFAXINE

Product NDC
70518-3450
11-digit product format
705183450
Labeler code
70518
Product ID
70518-3450_e569a8c8-1e17-e539-e053-2a95a90a80d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078554
Marketing category
ANDA
Marketing start
2022-07-14
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
50 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70518-3450DDiscontinued by firm2026-08-07
excluded packagepackage70518-345070518-3450-0DDiscontinued by firm2026-08-07

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 · 22 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3450-0DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3450-0DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3450-0DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3450-0DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3450-0DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3450-0DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3450-0DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3450-0DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3450-0DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage70518-3450-0DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage70518-3450-0IInactivated by FDA1332a3947898…d4bfe170f9cd…

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
A078554-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09
A078554-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09
A078554-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09
A078554-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09
A078554-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078554-001AB
A078554-002AB
A078554-003AB
A078554-004AB
A078554-005AB

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 UTC2026-02A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…

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 UTC2026-02A078554-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078554-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-005AB15bbf6a4d5a75…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-3450-02024-03-20C16284748780-11030e365-4664-111a-e063-dadaa90a10e2Venlafaxine Tablets, USP Rx only
70518-3450-02024-01-30C16284748780-11030e365-4664-111a-e063-dadaa90a10e2Venlafaxine Tablets, USP Rx only

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VENLAFAXINEVENLAFAXINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.80ac757d-c629-4579-8afd-cae0ee9cd6142026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078554
application number: ANDA078554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3450-070518345000.3 TABLET in 1 BLISTER PACK (70518-3450-0) 2022-07-140000-00-00NoNoCurrent