Home NDC 61919-535-60 VENLAFAXINE
Product NDC 61919-535
Requested package NDC 61919-535-60
11-digit product format 619190535
Labeler code 61919
Product ID 61919-535_9cad8725-3ed8-9045-e053-2a95a90a5b88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name VENLAFAXINE
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 75 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 · 16 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2019-12-08 06:16 UTC · source 2019-12-05 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 A078554-001 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 A078554-002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 A078554-003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 A078554-004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 A078554-005 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09
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 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078554-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL AB 2009-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078554-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL AB 2009-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078554-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL AB 2009-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078554-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL AB 2009-01-09 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078554-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL AB 2009-01-09 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 61919-535-30 VENLAFAXINE 30 in 1 BOTTLE TABLET 30 3 61919-535-60 VENLAFAXINE 60 in 1 BOTTLE TABLET 60 3
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61919-535 VENLAFAXINE TABLET [DIRECT RX] 3 Legacy NDC, 2 package rows 20200131_6490e629-062b-4caa-a0aa-3d9c75c693d7.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VENLAFAXINE VENLAFAXINE Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 80ac757d-c629-4579-8afd-cae0ee9cd614 2026-06-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 078554 application number: ANDA078554
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 61919-535-60 61919053560 60 BOTTLE in 1 BOTTLE (61919-535-60) > 30 TABLET in 1 BOTTLE (61919-535-30) 60 bottle 2014-03-27 0000-00-00 No No Current