Venlafaxine Hydrochloride

Product NDC
13811-714
11-digit product format
138110714
Labeler code
13811
Product ID
13811-714_55564637-0e7a-4684-be84-9d8c4cecacc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Trigen Laboratories, LLC
Application
NDA022104
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-04-29
Marketing end
2026-05-31
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

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 productproduct13811-714DDiscontinued by firm2026-08-11
excluded packagepackage13811-71413811-714-30DDiscontinued by firm2026-08-11
excluded packagepackage13811-71413811-714-90DDiscontinued by firm2026-08-11

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…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13811-714-30Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE3014
13811-714-90Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13811-714-30EA - Each13811-71457b2f3f6-7a0b-4582-b261-9b18dba8ff0a12016-12-07
13811-714-90EA - Each13811-71496dc73ed-108b-4f99-a808-7f2a861d3ed112016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13811-714VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [TRIGEN LABORATORIES, LLC]11Current NDC, Legacy NDC, 2 package rows20240606_fdaed1c2-dd0a-4bf3-975a-86fe3e7f0c97.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
ndc (product): 13811-714
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808744venlafaxine HCl 150 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808748venlafaxine HCl 225 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808751venlafaxine HCl 37.5 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSNfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80874424 HR venlafaxine 150 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80874824 HR venlafaxine 225 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80875124 HR venlafaxine 37.5 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCDfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808744venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808744venlafaxine 150 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808748venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808748venlafaxine 225 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808751venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808751venlafaxine 37.5 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSYfdaed1c2-dd0a-4bf3-975a-86fe3e7f0c9714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
13811-714-301381107143030 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-714-30) 2010-04-292026-05-31NoNoCurrent
13811-714-901381107149090 TABLET, EXTENDED RELEASE in 1 BOTTLE (13811-714-90) 2010-04-292026-05-31NoNoCurrent