venlafaxine

Product NDC
63187-752
11-digit product format
631870752
Labeler code
63187
Product ID
63187-752_0a1e4108-e2a9-4c22-ab48-900d3bc20c1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA078932
Marketing category
ANDA
Marketing start
2015-10-01
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 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
A078932-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-14
A078932-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-14
A078932-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-14
A078932-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-14
A078932-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078932-001AB
A078932-002AB
A078932-003AB
A078932-004AB
A078932-005AB

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 UTC2026-02A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-12-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-12-145bbf6a4d5a75…

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 UTC2026-02A078932-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078932-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078932-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078932-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078932-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078932-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078932-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078932-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078932-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078932-005AB15bbf6a4d5a75…

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313580Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cc3a1258-aafb-48cf-86f7-fcf59e0c6cddAvailable 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-752-30venlafaxine30 in 1 BOTTLETABLET304
63187-752-60venlafaxine60 in 1 BOTTLETABLET604
63187-752-90venlafaxine90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-752-30EA - Each63187-75226a6533f-1d21-4e23-8100-ea7afa1f504e12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-752VENLAFAXINE TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20200121_cc3a1258-aafb-48cf-86f7-fcf59e0c6cdd.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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
venlafaxineVENLAFAXINECoupler LLC53c29dd9-a4d2-7537-e063-6294a90a290f2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINESt Mary's Medical Park Pharmacy70d47b50-5722-3868-e053-2991aa0af85e2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINECoupler LLC52ce8a81-d7fc-cc97-e063-6394a90a52362026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINENorthwind Health Company, LLCdabfa0f2-0060-f0ee-e053-2a95a90aec9b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINENorthwind Health Company, LLCdb5f1693-ca64-7a97-e053-2995a90acbff2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEREMEDYREPACK INC.e14bfb9f-3bd2-4419-9294-9c286e79730a2025-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.fda14f3f-b32c-42fe-e053-6294a90a103f2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEA-S Medication Solutionsab58f3ef-1fd3-4c68-861f-20d8fdd1b4332024-12-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINENuCare Pharmaceuticals,Inc.1ce9121b-aaa0-a5bb-e063-6394a90a2f3c2024-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEProficient Rx LPded77a84-e6d1-4471-ac6e-a05a0955daa52024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEProficient Rx LP470ad045-6c82-4e44-8e88-0e2b01a41ff22024-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEBryant Ranch Prepack0c9511a2-c581-44cd-bf38-a751fcc658e42024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEAlembic Pharmaceuticals Inc.67b323a7-a8c9-410f-bff0-0e515bef41a72023-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEAlembic Pharmaceuticals Limitedb73da6e2-1494-436f-a204-2e4e4c5974b62023-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
venlafaxineVENLAFAXINEProficient Rx LPcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd2020-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078932
application number: ANDA078932
ndc (product): 63187-752

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSNcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd4
313580venlafaxine 100 MG Oral TabletSCDcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd4
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSYcc3a1258-aafb-48cf-86f7-fcf59e0c6cdd4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-752-306318707523030 TABLET in 1 BOTTLE (63187-752-30) 30 tablet2016-10-030000-00-00NoNoCurrent
63187-752-606318707526060 TABLET in 1 BOTTLE (63187-752-60) 60 tablet2016-10-030000-00-00NoNoCurrent
63187-752-906318707529090 TABLET in 1 BOTTLE (63187-752-90) 90 tablet2016-10-030000-00-00NoNoCurrent