Home NDC 61919-938 EFFEXOR
Product NDC 61919-938
11-digit product format 619190938
Labeler code 61919
Product ID 61919-938_9c938f03-01d8-82c4-e053-2a95a90a37ad
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VENLAFAXINE
Dosage form TABLET
Route ORAL
Labeler DIRECT RX
Application ANDA078627
Marketing category ANDA
Marketing start 2016-02-02
Marketing end 0000-00-00
Substance VENLAFAXINE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 · 32 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 61919-938-30 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 61919-938-30 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 61919-938-30 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 61919-938-30 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 61919-938-30 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 61919-938-30 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 61919-938-30 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 61919-938-30 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 61919-938-30 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 61919-938-30 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 61919-938-30 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 61919-938-30 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 61919-938-30 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 61919-938-30 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 61919-938-30 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 61919-938-30 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078627-001 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 A078627-002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 A078627-003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 A078627-004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 A078627-005 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 5 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078627-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2008-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078627-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2008-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078627-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2008-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078627-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2008-06-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078627-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2008-06-13 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 6 · 205 observed states.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61919-938-30 EFFEXOR 30 in 1 BOTTLE TABLET 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-938 EFFEXOR (VENLAFAXINE) TABLET [DIRECT RX] 2 Legacy NDC, 1 package rows 20200121_3423487c-80e3-6bff-e054-00144ff88e88.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 · 4 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Venlafaxine VENLAFAXINE PD-Rx Pharmaceuticals, Inc. 18495527-add4-42a5-bbf7-9f8dc2df06af 2026-05-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627 Venlafaxine VENLAFAXINE Golden State Medical Supply, Inc. c2a3283f-ba30-f506-e053-2995a90a9378 2026-04-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627 Venlafaxine VENLAFAXINE Sun Pharmaceutical Industries, Inc. 55889b3d-74c9-4638-9a14-6a4ca3a99f7f 2026-02-11 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627 Venlafaxine VENLAFAXINE Aphena Pharma Solutions - Tennessee, LLC 2887a463-2da1-4f8d-afef-f4c88d31e04d 2021-11-05 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078627 application number: ANDA078627
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 61919-938-30 61919093830 30 TABLET in 1 BOTTLE (61919-938-30) 30 tablet 2016-02-02 0000-00-00 No No Current