Venlafaxine

Product NDC: 16714-659
11-digit product format: 167140659
Labeler code: 16714
Product ID: 16714-659_ee8cb936-5e51-e8a6-e053-2a95a90a4278
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine
Dosage form: TABLET
Route: ORAL
Labeler: Northstar Rx LLC
Application: ANDA078627
Marketing category: ANDA
Marketing start: 2017-01-26
Marketing end: 2024-09-30
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 100 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: 0000-00-00
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	16714-659		D	Discontinued by firm		2026-08-07
excluded package	package	16714-659	16714-659-01	D	Discontinued by firm		2026-08-07

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 · 22 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	16714-659-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	16714-659-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	16714-659-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	16714-659-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	16714-659-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	16714-659-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	16714-659-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	16714-659-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	16714-659-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	16714-659-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	16714-659-01	`367a005e9d99…`	`383a685ebd0f…`

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	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.

Application-product, TE code table
Application-product	TE code
A078627-001	AB
A078627-002	AB
A078627-003	AB
A078627-004	AB
A078627-005	AB

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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A078627-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078627-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078627-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078627-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078627-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078627-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078627-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078627-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078627-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078627-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078627-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078627-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078627-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078627-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078627-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078627-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078627-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078627-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078627-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078627-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078627-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078627-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078627-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078627-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078627-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078627-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078627-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078627-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078627-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078627-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078627-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078627-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078627-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078627-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078627-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078627-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078627-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078627-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078627-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078627-005	AB	1	`5bbf6a4d5a75…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16714-659-01	EA - Each	16714-659	a5a97669-c146-491b-b704-763c3271c2dd	1	2017-03-06

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE	99300-78-4	VENLAFAXINE HYDROCHLORIDE
GRZ5RCB1QG	VENLAFAXINE	93413-69-5	Venlafaxine

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
16714-659-01	16714065901	100 TABLET in 1 BOTTLE (16714-659-01)	100 tablet	2017-01-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Tablets, USP	Northstar Rx LLC \| ALKALOIDA chemical company Zrt	2024-07-22	HUMAN PRESCRIPTION DRUG LABEL	10