Venlafaxine Hydrochloride

Product NDC
45865-643
Requested package NDC
45865-643-60
11-digit product format
458650643
Labeler code
45865
Product ID
45865-643_9ab35ec5-4dd6-d09d-e053-2a95a90a2fa8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
NDA020699
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2011-06-10
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
2020-12-31
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 packagepackage45865-64345865-643-60IInactivated 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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
N020699-001EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20
N020699-002EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20
N020699-003EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1997-10-20
N020699-004EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
N020699-001AB
N020699-002AB
N020699-004AB

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 UTC2026-02N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-003EFFEXOR XREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N020699-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020699-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020699-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020699-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020699-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020699-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020699-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020699-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020699-004AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020699-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020699-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020699-004AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020699-001AB18072bd15b7f6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-643-30Venlafaxine Hydrochloride30 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE303
45865-643-60Venlafaxine Hydrochloride60 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE603

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-643VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 2 package rows20191228_1f808a76-4837-687f-e054-00144ff88e88.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Effexor XRVENLAFAXINE HYDROCHLORIDEViatris Specialty LLCc848a5d8-ba94-4c84-80e3-0bf35fb8e32e2023-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020699
application number: NDA020699

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1f808a76-4837-687f-e054-00144ff88e883
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1f808a76-4837-687f-e054-00144ff88e883
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1f808a76-4837-687f-e054-00144ff88e883
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1f808a76-4837-687f-e054-00144ff88e883
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1f808a76-4837-687f-e054-00144ff88e883
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1f808a76-4837-687f-e054-00144ff88e883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45865-643-604586506436060 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (45865-643-60) 2015-09-110000-00-00NoNoCurrent