Venlafaxine Hydrochloride

Product NDC
50771-005
Requested package NDC
50771-005-02
11-digit product format
507710005
Labeler code
50771
Product ID
50771-005_4502de86-571d-cfb3-e063-6294a90a34f8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Yaopharma Co., Ltd.
Application
ANDA202036
Marketing category
ANDA
Marketing start
2016-09-06
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
100 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 42.

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
A202036-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-28
A202036-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-28
A202036-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-28
A202036-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-28
A202036-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A202036-001AB
A202036-002AB
A202036-003AB
A202036-004AB
A202036-005AB

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-28caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2015-05-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2015-05-282680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A202036-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202036-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202036-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202036-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202036-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202036-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202036-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202036-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202036-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202036-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202036-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE100 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 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313580Internal RxNorm lookup
313582Internal RxNorm lookup
313584Internal RxNorm lookup
313586Internal RxNorm lookup
314277Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
38fd2c97-cd30-2f7d-e054-00144ff8d46cAvailable 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
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50771-005-022024-01-30C16284748780-11030e365-4501-111a-e063-dadaa90a10e2VENLAFAXINE TABLETS, USP Rx only
50771-005-022024-01-30C16284748780-11030e365-4501-111a-e063-dadaa90a10e2VENLAFAXINE TABLETS, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50771-005-02Venlafaxine Hydrochloride100 in 1 BOTTLE, PLASTICTABLET10019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50771-005VENLAFAXINE HYDROCHLORIDE TABLET [YAOPHARMA CO., LTD.]17Current NDC, Legacy NDC, 1 package rows20241220_38fd2c97-cd30-2f7d-e054-00144ff8d46c.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
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEYaopharma Co., Ltd.38fd2c97-cd30-2f7d-e054-00144ff8d46c2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202036
application number: ANDA202036
ndc (package): 50771-005-02
ndc (product): 50771-005
ndc11 (package): 50771000502

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313582venlafaxine HCl 25 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313584venlafaxine HCl 37.5 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
314277venlafaxine HCl 50 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313586venlafaxine HCl 75 MG Oral TabletPSN38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313580venlafaxine 100 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313582venlafaxine 25 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313584venlafaxine 37.5 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
314277venlafaxine 50 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313586venlafaxine 75 MG Oral TabletSCD38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY38fd2c97-cd30-2f7d-e054-00144ff8d46c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50771-005-0250771000502100 TABLET in 1 BOTTLE, PLASTIC (50771-005-02) 100 tablet2016-09-060000-00-00NoNoCurrent