venlafaxine hydrochloride

Product NDC
16714-045
Requested package NDC
16714-045-01
11-digit product format
167140045
Labeler code
16714
Product ID
16714-045_522af844-d0ec-454e-8117-02528fb7cb33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Northstar Rx LLC.
Application
ANDA090174
Marketing category
ANDA
Marketing start
2021-06-10
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
150 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
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage16714-04516714-045-01DDiscontinued 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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
A090174-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A090174-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14
A090174-003VENLAFAXINE 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
A090174-001AB
A090174-002AB
A090174-003AB

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 UTC2026-02A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090174-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090174-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090174-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2011-04-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090174-001VENLAFAXINE 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 UTC2026-02A090174-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090174-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090174-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090174-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090174-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090174-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090174-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090174-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090174-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090174-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090174-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090174-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A090174-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090174-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090174-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090174-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090174-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090174-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090174-001AB18072bd15b7f6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-045-01EA - Each16714-045c5e7c505-355f-479c-957b-20e693c421b612021-08-05

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.c4312b7b-7a42-45f1-b6e6-e20ea76020c42026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.9fda0f8d-b24e-4581-9dca-7aaaf86e24132026-01-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEPreferred Pharmaceuticals Inc.de6e30f8-c8ef-4016-b228-0f188645347b2025-10-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.6cb943a8-5972-292f-e053-2991aa0ae3ee2024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited1be1be3a-304b-4e31-8732-3352470291912023-09-28Exact identifier
application applno (ANDA): 090174
application number: ANDA090174
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Lifesciences Limited1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b2023-05-19Exact identifier
application applno (ANDA): 090174
application number: ANDA090174
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEBryant Ranch Prepackf02cc6e8-186f-46e8-9675-70fd55d002c42023-03-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEA-S Medication Solutions8d6e699b-24bf-4e77-8a7f-acd496a700c72023-01-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174
venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.5351fe67-17d9-42ec-9e8b-6585fdb9e29e2022-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090174
application number: ANDA090174

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-045-011671400450190 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16714-045-01) 2021-06-100000-00-00NoNoCurrent