Venlafaxine Hydrochloride

Product NDC
70518-2107
11-digit product format
705182107
Labeler code
70518
Product ID
70518-2107_499ef330-088a-7248-e063-6394a90af248
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA200834
Marketing category
ANDA
Marketing start
2019-05-23
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70518-210770518-2107-0DDiscontinued by firm2026-08-11
excluded packagepackage70518-210770518-2107-1DDiscontinued by firm2026-08-11
excluded packagepackage70518-210770518-2107-2DDiscontinued 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 · 23 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0570518-2107-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2107-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0570518-2107-0d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2670518-2107-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2107-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2670518-2107-0f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3170518-2107-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3170518-2107-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2870518-2107-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2870518-2107-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2170518-2107-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2170518-2107-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1070518-2107-0cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1070518-2107-2cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3170518-2107-0302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3170518-2107-2302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2070518-2107-0ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2070518-2107-2ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1070518-2107-00efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1070518-2107-20efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0870518-2107-2ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0370518-2107-2367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0970518-2107-2557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A200834-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A200834-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A200834-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A200834-001AB
A200834-002AB
A200834-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200834-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-148072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A200834-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A200834-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A200834-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A200834-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A200834-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A200834-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A200834-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A200834-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A200834-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A200834-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A200834-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A200834-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A200834-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A200834-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A200834-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A200834-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A200834-001AB18072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
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
313585Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac9b972d-8b8a-4727-90c2-b208f91272fdAvailable 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
70518-2107-0Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017
70518-2107-1Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017
70518-2107-2Venlafaxine Hydrochloride90 in 1 BOTTLE, PLASTICCAPSULE, EXTENDED RELEASE9017
70518-2107-3Venlafaxine Hydrochloride30 in 1 BOXCAPSULE, EXTENDED RELEASE3017
70518-2107-4Venlafaxine Hydrochloride1 in 1 POUCHCAPSULE, EXTENDED RELEASE117
70518-2107-5Venlafaxine Hydrochloride30 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE3017

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2107VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [REMEDYREPACK INC.]14Current NDC, Legacy NDC, 6 package rows20250306_ac9b972d-8b8a-4727-90c2-b208f91272fd.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 2 · 38 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4e3053b9-cdec-4f4d-85ae-2e55cf1cc1852026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.50d3b487-9f65-4e2f-b6eb-9533964f89722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ac9b972d-8b8a-4727-90c2-b208f91272fd2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
ndc (product): 70518-2107
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5358f20f-b864-0aae-e063-6394a90a7eab2026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECoupler LLC5359012e-a868-3aa3-e063-6294a90a74e22026-06-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEAsclemed USA, Inc.c69d16fd-b82d-4708-aece-ab4f60b29cc62026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions7852be9e-0c1d-47a8-9513-c3a04b3657632026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions28c8f404-1dbd-4140-8959-32624d7c77242026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDECardinal Health 107, LLC7588ffdc-034d-4baf-9889-9a0ded265be52026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions33068acd-d361-4cd9-b994-02a7865ff04f2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions812ca864-8230-4c84-a7f4-d1b926dee31a2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions569e10d1-6432-473c-a026-ac438bd77bcd2026-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HCL ERVENLAFAXINE HCL ERDirect_Rxf32ca617-66e0-41d8-e053-2a95a90ae40a2026-03-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEQPharma, Inc.4992698e-5d5a-6468-e063-6394a90ab4042026-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.e2d5a2d5-5e55-426c-bc8d-d29729eba7752026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENorthwind Health Company, LLCf757cac4-efa7-668c-e053-6294a90a720d2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEMajor Pharmaceuticalsd962f5af-7642-4c6e-b7be-3e089fe488732025-10-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.22980b32-cbae-4f37-9fc0-b47221b2c32e2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.0c404290-2806-4756-bca3-2d639b4009632025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 200834
application number: ANDA200834

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNac9b972d-8b8a-4727-90c2-b208f91272fd17
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDac9b972d-8b8a-4727-90c2-b208f91272fd17
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYac9b972d-8b8a-4727-90c2-b208f91272fd17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2107-07051821070030 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-0) 2019-05-230000-00-00NoNoCurrent
70518-2107-17051821070130 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-1) 2020-08-310000-00-00NoNoCurrent
70518-2107-27051821070290 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-2107-2) 2022-02-170000-00-00NoNoCurrent
70518-2107-37051821070330 POUCH in 1 BOX (70518-2107-3) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2107-4) 30 pouch2023-08-26NoNoCurrent
70518-2107-4705182107041 in 1 POUCHHistorical
70518-2107-57051821070530 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (70518-2107-5) 2025-07-31NoNoCurrent
70518-2107-67051821070650 POUCH in 1 BOX (70518-2107-6) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-2107-4)50 pouch2026-07-080Current