Venlafaxine Hydrochloride

Product NDC
68788-8825
11-digit product format
687888825
Labeler code
68788
Product ID
68788-8825_edefc932-d25d-4ead-b348-b3b6d9232091
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA216044
Marketing category
ANDA
Marketing start
2025-02-10
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
75 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216044-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28
A216044-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28
A216044-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28
A216044-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A216044-001AB
A216044-002AB
A216044-003AB
A216044-004AB

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 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216044-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A216044-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A216044-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A216044-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2022-11-28d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216044-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216044-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216044-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A216044-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216044-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216044-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216044-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216044-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A216044-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216044-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216044-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216044-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216044-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216044-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216044-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216044-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216044-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216044-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A216044-004AB1d06236e962d9…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 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
808753Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
edefc932-d25d-4ead-b348-b3b6d9232091Available 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
68788-8825-3Venlafaxine Hydrochloride30 in 1 BOTTLETABLET, EXTENDED RELEASE301
68788-8825-6Venlafaxine Hydrochloride60 in 1 BOTTLETABLET, EXTENDED RELEASE601
68788-8825-9Venlafaxine Hydrochloride90 in 1 BOTTLETABLET, EXTENDED RELEASE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8825-3EA - Each68788-882574557c53-e9d9-4ac6-a87d-074e3bfea27a12025-03-04
68788-8825-6EA - Each68788-882528b9d82d-5882-43fd-8c13-7c1c693ded1912025-03-04
68788-8825-9EA - Each68788-8825d5d3e1a5-9568-4f3f-b9ba-142a241c412412025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8825VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250212_edefc932-d25d-4ead-b348-b3b6d9232091.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINEREMEDYREPACK INC.9df3a51c-1b89-4d2a-8f41-3755910e9bfb2025-09-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216044
application number: ANDA216044
Venlafaxine HydrochlorideVENLAFAXINERising Pharma Holdings, Inc.074f4478-e81b-45a2-ae85-ffd27bed940f2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216044
application number: ANDA216044
Venlafaxine HydrochlorideVENLAFAXINEPreferred Pharmaceuticals Inc.edefc932-d25d-4ead-b348-b3b6d92320912025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216044
application number: ANDA216044
ndc (product): 68788-8825

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSNedefc932-d25d-4ead-b348-b3b6d92320911
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCDedefc932-d25d-4ead-b348-b3b6d92320911
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSYedefc932-d25d-4ead-b348-b3b6d92320911
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSYedefc932-d25d-4ead-b348-b3b6d92320911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8825-36878888250330 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-3) 2025-02-10NoNoCurrent
68788-8825-66878888250660 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-6) 2025-02-10NoNoCurrent
68788-8825-96878888250990 TABLET, EXTENDED RELEASE in 1 BOTTLE (68788-8825-9) 2025-02-10NoNoCurrent