VENLAFAXINE

Product NDC
23155-250
11-digit product format
231550250
Labeler code
23155
Product ID
23155-250_c19d98d7-0180-40b2-97dd-507bb3f69327
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA078554
Marketing category
ANDA
Marketing start
2021-07-19
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
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
A078554-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09
A078554-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09
A078554-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09
A078554-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09
A078554-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078554-001AB
A078554-002AB
A078554-003AB
A078554-004AB
A078554-005AB

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 UTC2026-02A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…

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 UTC2026-02A078554-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078554-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-005AB15bbf6a4d5a75…

Additional Listing Data#

Finished product
Yes
Brand name base
VENLAFAXINE
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
80ac757d-c629-4579-8afd-cae0ee9cd614Available 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
23155-250-01VENLAFAXINE100 in 1 BOTTLETABLET10022
23155-250-09VENLAFAXINE90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-250-01EA - Each23155-25036d39336-a20d-4d68-98ee-2a14397e1b5512013-02-13
23155-250-09EA - Each23155-250d05c9270-d07a-4876-9deb-da06554a35b312013-11-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
POVIDONEINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-250VENLAFAXINE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]21Current NDC, Legacy NDC, 2 package rows20231228_80ac757d-c629-4579-8afd-cae0ee9cd614.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
VENLAFAXINEVENLAFAXINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.80ac757d-c629-4579-8afd-cae0ee9cd6142026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078554
application number: ANDA078554
ndc (product): 23155-250

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313580venlafaxine HCl 100 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine HCl 25 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine HCl 37.5 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine HCl 50 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine HCl 75 MG Oral TabletPSN80ac757d-c629-4579-8afd-cae0ee9cd61422
313580venlafaxine 100 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine 25 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine 37.5 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine 50 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine 75 MG Oral TabletSCD80ac757d-c629-4579-8afd-cae0ee9cd61422
313580venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313582venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
314277venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY80ac757d-c629-4579-8afd-cae0ee9cd61422

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-250-0123155025001100 TABLET in 1 BOTTLE (23155-250-01) 100 tablet2021-07-192027-06-30NoNoCurrent
23155-250-092315502500990 TABLET in 1 BOTTLE (23155-250-09) 90 tablet2021-07-190000-00-00NoNoCurrent