venlafaxine

Product NDC
51655-332
11-digit product format
516550332
Labeler code
51655
Product ID
51655-332_48eb112c-b597-7c26-e063-6394a90a4bf2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078932
Marketing category
ANDA
Marketing start
2021-06-10
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
2027-12-31
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
2027-12-31

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
313584Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
dabfa0f2-0060-f0ee-e053-2a95a90aec9bAvailable 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
51655-332-52venlafaxine30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-332VENLAFAXINE TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 1 package rows20241219_dabfa0f2-0060-f0ee-e053-2a95a90aec9b.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
ndc (product): 51655-332
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSNdabfa0f2-0060-f0ee-e053-2a95a90aec9b4
313584venlafaxine 37.5 MG Oral TabletSCDdabfa0f2-0060-f0ee-e053-2a95a90aec9b4
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSYdabfa0f2-0060-f0ee-e053-2a95a90aec9b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-332-525165503325230 TABLET in 1 BOTTLE, PLASTIC (51655-332-52) 30 tablet2021-06-10NoNoCurrent