Home NDC 50268-801 Venlafaxine Hydrochloride
Product NDC 50268-801
11-digit product format 502680801
Labeler code 50268
Product ID 50268-801_d5e0a7e8-d026-d2cf-e053-2995a90a4d7d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Venlafaxine
Dosage form TABLET
Route ORAL
Labeler AvPAK
Application ANDA079098
Marketing category ANDA
Marketing start 2016-06-06
Marketing end 0000-00-00
Substance VENLAFAXINE HYDROCHLORIDE
Active strength 75 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
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 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A079098-001 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 A079098-002 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 A079098-003 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 A079098-004 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 A079098-005 VENLAFAXINE HYDROCHLORIDE VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11
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 · 215 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 2026-09-14 22:38:34 2026-08 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079098-001 VENLAFAXINE HYDROCHLORIDE EQ 25MG BASE TABLET / ORAL 2010-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079098-002 VENLAFAXINE HYDROCHLORIDE EQ 37.5MG BASE TABLET / ORAL 2010-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079098-003 VENLAFAXINE HYDROCHLORIDE EQ 50MG BASE TABLET / ORAL 2010-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079098-004 VENLAFAXINE HYDROCHLORIDE EQ 75MG BASE TABLET / ORAL 2010-05-11 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A079098-005 VENLAFAXINE HYDROCHLORIDE EQ 100MG BASE TABLET / ORAL 2010-05-11 03ed91905a0d…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 140 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50268-801-13 50268080113 30 BLISTER PACK in 1 BOX (50268-801-13) > 1 TABLET in 1 BLISTER PACK (50268-801-11) 30 blister pack 2019-02-05 0000-00-00 No No Current