Venlafaxine Hydrochloride

Product NDC
80425-0477
Requested package NDC
80425-0477-2
11-digit product format
804250477
Labeler code
80425
Product ID
80425-0477_2d034ebe-1e07-6fe0-e063-6394a90a368b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
NDA022104
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-01-30
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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
2026-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-2084e616aacf4f…
2026-09-14 22:38:342026-08N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-2084e616aacf4f…
2026-08-18 06:07:402026-07N022104-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20caaa826d4ba7…
2026-08-18 06:07:402026-07N022104-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20caaa826d4ba7…
2026-08-18 06:07:402026-07N022104-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALABRLD, RS2008-05-20caaa826d4ba7…
2026-08-18 06:07:402026-07N022104-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALABRLD2008-05-20caaa826d4ba7…
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…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N022104-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N022104-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N022104-003AB184e616aacf4f…
2026-09-14 22:38:342026-08N022104-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N022104-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022104-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022104-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N022104-004AB1caaa826d4ba7…
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…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7D7RX5A8MOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
808751Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2cf6e6ad-7d00-0db1-e063-6394a90ab1ecAvailable on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0477-1Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE302
80425-0477-2Venlafaxine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE602
80425-0477-3Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0477-1EA - Each80425-047739e5e5ca-6655-403e-ba4d-7e1084c6768912025-03-04
80425-0477-2EA - Each80425-047713cdee5a-42f8-452b-8a42-91036a74a94912025-03-04
80425-0477-3EA - Each80425-04774a0eebb3-a622-477f-b111-a35026b9e66012025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0477VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [ADVANCED RX OF TENNESSEE, LLC]2Current NDC, 3 package rows20250201_2cf6e6ad-7d00-0db1-e063-6394a90ab1ec.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
ndc (package): 80425-0477-2
ndc (product): 80425-0477
ndc11 (package): 80425047702

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSN2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCD2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSY2cf6e6ad-7d00-0db1-e063-6394a90ab1ec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
80425-0477-28042504770260 TABLET, EXTENDED RELEASE in 1 BOTTLE (80425-0477-2) 2025-01-30NoNoCurrent