Venlafaxine

Product NDC
70518-3820
11-digit product format
705183820
Labeler code
70518
Product ID
70518-3820_4f5c6f4c-8405-a341-e063-6394a90abda8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA214127
Marketing category
ANDA
Marketing start
2023-08-03
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
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-382070518-3820-1DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3820-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-3820-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage70518-3820-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage70518-3820-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage70518-3820-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage70518-3820-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage70518-3820-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage70518-3820-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage70518-3820-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage70518-3820-10efc9e666f02…f202fb6c5f17…

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
A214127-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10
A214127-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10
A214127-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10
A214127-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A214127-001AB
A214127-002AB
A214127-003AB
A214127-004AB

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 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-102680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-105bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214127-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214127-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214127-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d06236e962d9…
2024-10-29 15:01 UTC2024-10A214127-004VENLAFAXINE HYDROCHLORIDEEQ 225MG BASETABLET, EXTENDED RELEASE / ORALAB2021-06-10d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A214127-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214127-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214127-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A214127-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A214127-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A214127-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214127-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214127-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A214127-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A214127-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A214127-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A214127-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A214127-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A214127-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A214127-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A214127-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214127-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214127-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A214127-004AB1d06236e962d9…

Additional Listing Data#

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

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
1ce5786e-22e6-4afa-8052-6eababc6aa4eAvailable 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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3820-0Venlafaxine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE907
70518-3820-1Venlafaxine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE307

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3820VENLAFAXINE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.]5Current NDC, 2 package rows20241128_1ce5786e-22e6-4afa-8052-6eababc6aa4e.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
VenlafaxineVENLAFAXINEREMEDYREPACK INC.1ce5786e-22e6-4afa-8052-6eababc6aa4e2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214127
application number: ANDA214127
ndc (product): 70518-3820
VenlafaxineVENLAFAXINEREMEDYREPACK INC.4b23e4bd-b6ab-42f2-b389-0be0b7e11b922025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214127
application number: ANDA214127
VenlafaxineVENLAFAXINEAscend Laboratories, LLC528d5392-4ad5-48c5-963d-6ebfb9187db42024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 214127
application number: ANDA214127

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808753venlafaxine HCl 75 MG 24HR Extended Release Oral TabletPSN1ce5786e-22e6-4afa-8052-6eababc6aa4e7
80875324 HR venlafaxine 75 MG Extended Release Oral TabletSCD1ce5786e-22e6-4afa-8052-6eababc6aa4e7
808753venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral TabletSY1ce5786e-22e6-4afa-8052-6eababc6aa4e7
808753venlafaxine 75 MG 24 HR Extended Release Oral TabletSY1ce5786e-22e6-4afa-8052-6eababc6aa4e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-3820-07051838200090 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3820-0) 2023-08-03NoNoCurrent
70518-3820-17051838200130 in 1 BOTTLE, PLASTICHistorical