VENLAFAXINE HYDROCHLORIDE

Product NDC
61919-644
11-digit product format
619190644
Labeler code
61919
Product ID
61919-644_349e5c25-36f3-0398-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078554
Marketing category
ANDA
Marketing start
2014-01-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct61919-644UExcluded because listing certification expired2026-08-07
excluded packagepackage61919-64461919-644-60UExcluded because listing certification expired2026-08-07

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductUExcluded because listing certification expiredd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage61919-644-60UExcluded because listing certification expiredd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductUExcluded because listing certification expiredf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage61919-644-60UExcluded because listing certification expiredf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductUExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage61919-644-60UExcluded because listing certification expired2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductUExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage61919-644-60UExcluded because listing certification expireda1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductUExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage61919-644-60UExcluded because listing certification expiredcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductUExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage61919-644-60UExcluded because listing certification expiredcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage61919-644-60UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage61919-644-60UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage61919-644-60UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductUExcluded because listing certification expiredad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage61919-644-60UExcluded because listing certification expiredad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductUExcluded because listing certification expired367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage61919-644-60UExcluded because listing certification expired367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductUExcluded because listing certification expired557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage61919-644-60UExcluded because listing certification expired557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductUExcluded because listing certification expired8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage61919-644-60UExcluded because listing certification expired8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductUExcluded because listing certification expired834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage61919-644-60UExcluded because listing certification expired834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductUExcluded because listing certification expired1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage61919-644-60UExcluded because listing certification expired1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductUExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage61919-644-60UExcluded because listing certification expiredfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductUExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage61919-644-60UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductUExcluded because listing certification expiredbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage61919-644-60UExcluded because listing certification expiredbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductUExcluded because listing certification expired8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage61919-644-60UExcluded because listing certification expired8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductEExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61919-644-60EExcluded after deficient or non-compliant submission was not correctede2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductEExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61919-644-60EExcluded after deficient or non-compliant submission was not corrected9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage61919-644-60EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A078554-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09
A078554-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09
A078554-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09
A078554-004VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09
A078554-005VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078554-001AB
A078554-002AB
A078554-003AB
A078554-004AB
A078554-005AB

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 UTC2026-02A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-001VENLAFAXINE HYDROCHLORIDEEQ 25MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-002VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-003VENLAFAXINE HYDROCHLORIDEEQ 50MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-004VENLAFAXINE HYDROCHLORIDEEQ 75MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-005VENLAFAXINE HYDROCHLORIDEEQ 100MG BASETABLET / ORALAB2009-01-095bbf6a4d5a75…

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 UTC2026-02A078554-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078554-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078554-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A078554-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078554-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078554-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078554-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078554-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078554-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078554-005AB15bbf6a4d5a75…

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
61919-644-60VENLAFAXINE HYDROCHLORIDE60 in 1 BOTTLETABLET602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-644-60EA - Each61919-6446388f3be-d8bb-4c11-bc45-044c579c3c3712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-644VENLAFAXINE HYDROCHLORIDE TABLET [DIRECT RX]2Legacy NDC, 1 package rows20161027_1756bedd-c8d7-434a-beb0-bb3c7bd3e558.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VENLAFAXINEVENLAFAXINEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.80ac757d-c629-4579-8afd-cae0ee9cd6142026-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078554
application number: ANDA078554

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN1756bedd-c8d7-434a-beb0-bb3c7bd3e5582
313584venlafaxine 37.5 MG Oral TabletSCD1756bedd-c8d7-434a-beb0-bb3c7bd3e5582
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY1756bedd-c8d7-434a-beb0-bb3c7bd3e5582

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-644-606191906446060 in 1 BOTTLEHistorical