Venlafaxine Hydrochloride

Product NDC
63629-3323
11-digit product format
636293323
Labeler code
63629
Product ID
63629-3323_3d36ecb5-4c38-43df-b3e2-a3dad6056d74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA079098
Marketing category
ANDA
Marketing start
2010-05-11
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-3323DDiscontinued by firm2026-10-16
excluded packagepackage63629-332363629-3323-1DDiscontinued by firm2026-10-16
excluded packagepackage63629-332363629-3323-2DDiscontinued by firm2026-10-16
excluded packagepackage63629-332363629-3323-3DDiscontinued by firm2026-10-16
excluded packagepackage63629-332363629-3323-4DDiscontinued by firm2026-10-16

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 2 · 75 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 packagepackage63629-3323-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3323-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3323-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-3323-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3323-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3323-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3323-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-3323-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3323-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3323-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3323-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-3323-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3323-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3323-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3323-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-3323-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3323-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3323-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3323-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-3323-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3323-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3323-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3323-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-3323-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3323-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3323-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3323-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-3323-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3323-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3323-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3323-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-3323-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3323-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3323-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3323-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-3323-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3323-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3323-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3323-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-3323-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3323-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3323-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3323-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-3323-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3323-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3323-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3323-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-3323-3557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A079098-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11
A079098-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11
A079098-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11
A079098-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11
A079098-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11

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 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11c2088c7a36db…
2026-10-15 13:18:302026-09A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11c2088c7a36db…
2026-10-15 13:18:302026-09A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11c2088c7a36db…
2026-10-15 13:18:302026-09A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11c2088c7a36db…
2026-10-15 13:18:302026-09A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11c2088c7a36db…
2026-09-14 22:38:342026-08A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-09-14 22:38:342026-08A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-1184e616aacf4f…
2026-08-18 06:07:402026-07A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-08-18 06:07:402026-07A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORAL2010-05-11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079098-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORAL2010-05-11b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079098-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079098-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079098-003AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079098-004AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079098-005AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079098-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079098-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079098-003AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079098-004AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A079098-005AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079098-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079098-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079098-003AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079098-004AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A079098-005AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079098-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079098-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079098-003AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079098-004AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A079098-005AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079098-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079098-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079098-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079098-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A079098-005AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079098-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079098-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079098-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079098-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A079098-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079098-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079098-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079098-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079098-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A079098-005AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079098-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079098-002AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079098-003AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079098-004AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079098-005AB16a51e52b5d6a…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3323-1EA - Each63629-33230b74216d-0dc3-484e-9eff-03f980e06f6212013-02-13
63629-3323-2EA - Each63629-33233258c151-ac45-4b26-ac19-01af13daf43d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET [BRYANT RANCH PREPACK]1001
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET [BRYANT RANCH PREPACK]1001