venlafaxine

Product NDC
70518-1385
Requested package NDC
70518-1385-2
11-digit product format
705181385
Labeler code
70518
Product ID
70518-1385_48fb8b01-4fa8-be3f-e063-6394a90a0659
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA090555
Marketing category
ANDA
Marketing start
2018-08-24
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

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 packagepackage70518-138570518-1385-2DDiscontinued by firm2026-08-11

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70518-138570518-1385-2DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
A090555-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07
A090555-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07
A090555-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07
A090555-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07
A090555-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090555-001AB
A090555-002AB
A090555-003AB
A090555-004AB
A090555-005AB

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 UTC2026-02A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2010-04-075bbf6a4d5a75…

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 UTC2026-02A090555-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090555-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090555-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090555-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090555-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090555-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090555-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090555-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090555-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090555-005AB15bbf6a4d5a75…

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
4a82cef5-693e-46e9-90c4-bff753cdce37Available 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
70518-1385-0venlafaxine30 in 1 BLISTER PACKTABLET3018
70518-1385-1venlafaxine90 in 1 BOTTLE, PLASTICTABLET9018
70518-1385-2venlafaxine30 in 1 BOTTLE, PLASTICTABLET3018
70518-1385-3venlafaxine60 in 1 BOTTLE, PLASTICTABLET6018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1385VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 4 package rows20250223_4a82cef5-693e-46e9-90c4-bff753cdce37.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 · 13 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.f56a0f70-bbb1-4e69-b969-965a72f0e2f02026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4a82cef5-693e-46e9-90c4-bff753cdce372026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
ndc (package): 70518-1385-2
ndc (product): 70518-1385
ndc11 (package): 70518138502
venlafaxineVENLAFAXINE HYDROCHLORIDECoupler LLC53e5c5a2-b8e7-3d75-e063-6294a90a508b2026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ddb51556-0292-4aa9-b781-a402c912591f2026-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.b19ec628-4034-4316-ad3d-46c1ee2207282026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.806b3e38-3b2a-4aaa-973c-e2d921bb353e2026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCf2b5c729-17c8-7ecc-e053-2a95a90a2e532026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCfb076577-b9da-c78b-e053-6394a90a107b2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack304bda24-9151-47b5-9f62-005ea325a11e2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepack49e5833b-4693-45b5-9abb-1b369eb4086d2023-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
VenlafaxineVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limitedb23637e5-d37f-41b5-ba76-fc053e903bc22023-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDERising Pharma Holdings, Inc.20319949-ccf9-477a-a6e3-53502772deb92023-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555
venlafaxineVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions5bd03cf1-e8fc-44f3-9c41-06515b897f3b2023-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090555
application number: ANDA090555

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN4a82cef5-693e-46e9-90c4-bff753cdce3718
313584venlafaxine 37.5 MG Oral TabletSCD4a82cef5-693e-46e9-90c4-bff753cdce3718
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY4a82cef5-693e-46e9-90c4-bff753cdce3718

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1385-27051813850230 TABLET in 1 BOTTLE, PLASTIC (70518-1385-2) 30 tablet2021-02-010000-00-00NoNoCurrent