venlafaxine

Product NDC
67046-560
Requested package NDC
67046-560-30
11-digit product format
670460560
Labeler code
67046
Product ID
67046-560_bc2ee1aa-619f-0a14-e053-2a95a90a2c8a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Contract Pharmacy Services-PA
Application
ANDA090555
Marketing category
ANDA
Marketing start
2021-02-24
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67046-56067046-560-30IInactivated by FDA2026-08-11

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…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
A090555-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07
A090555-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07
A090555-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07
A090555-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07
A090555-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090555-001AB
A090555-002AB
A090555-003AB
A090555-004AB
A090555-005AB

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 UTC2026-02A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…

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 UTC2026-02A090555-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090555-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-005AB15bbf6a4d5a75…

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
67046-560-302023-01-30C16284748780-1f386c64a-2693-0266-e053-dadaa90a7c1aVenlafaxine Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67046-560-30venlafaxine30 in 1 BLISTER PACKTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67046-560VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [CONTRACT PHARMACY SERVICES-PA]1Legacy NDC, 1 package rows20210227_bc2eed44-ce99-4b90-e053-2a95a90a37d7.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.f56a0f70-bbb1-4e69-b969-965a72f0e2f02026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4a82cef5-693e-46e9-90c4-bff753cdce372026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDECoupler LLC53e5c5a2-b8e7-3d75-e063-6294a90a508b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ddb51556-0292-4aa9-b781-a402c912591f2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.b19ec628-4034-4316-ad3d-46c1ee2207282026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.806b3e38-3b2a-4aaa-973c-e2d921bb353e2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCf2b5c729-17c8-7ecc-e053-2a95a90a2e532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCfb076577-b9da-c78b-e053-6394a90a107b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack304bda24-9151-47b5-9f62-005ea325a11e2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack49e5833b-4693-45b5-9abb-1b369eb4086d2023-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
VenlafaxineVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limitedb23637e5-d37f-41b5-ba76-fc053e903bc22023-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDERising Pharma Holdings, Inc.20319949-ccf9-477a-a6e3-53502772deb92023-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions5bd03cf1-e8fc-44f3-9c41-06515b897f3b2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSNbc2eed44-ce99-4b90-e053-2a95a90a37d71
313584venlafaxine 37.5 MG Oral TabletSCDbc2eed44-ce99-4b90-e053-2a95a90a37d71
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYbc2eed44-ce99-4b90-e053-2a95a90a37d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67046-560-306704605603030 TABLET in 1 BLISTER PACK (67046-560-30) 30 tablet2021-02-240000-00-00NoNoCurrent