Venlafaxine Hydrochloride

Product NDC: 0378-4884
11-digit product format: 003784884
Labeler code: 0378
Product ID: 0378-4884_9ee29002-e238-4ff2-8cb3-11f8c77ea4b8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Mylan Pharmaceuticals Inc.
Application: ANDA077166
Marketing category: ANDA
Marketing start: 2008-06-14
Marketing end: 2020-12-31
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: 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	0378-4884		D	Discontinued by firm		2026-10-12
excluded package	package	0378-4884	0378-4884-01	D	Discontinued by firm		2026-10-12

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 · 24 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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`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	0378-4884-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0378-4884-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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	Approval date
A077166-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13
A077166-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13
A077166-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13
A077166-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13
A077166-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077166-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077166-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077166-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077166-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077166-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2008-06-13	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077166-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077166-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077166-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077166-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077166-005	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A077166-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077166-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077166-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077166-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077166-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077166-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077166-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077166-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077166-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077166-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077166-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077166-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077166-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077166-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077166-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077166-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077166-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077166-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077166-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077166-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077166-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077166-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077166-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077166-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077166-005	AB	1	`ea99ee380514…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4884-01	EA - Each	0378-4884	21aa9971-abf2-4d8b-bb8b-5ef1a9c5432b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE HYDROCHLORIDE TABLET [MYLAN PHARMACEUTICALS INC.]	7
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE	99300-78-4	VENLAFAXINE HYDROCHLORIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride - Mylan Institutional Inc.	Mylan Institutional Inc.	2019-12-30	HUMAN PRESCRIPTION DRUG LABEL	9
Venlafaxine Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2019-01-15	HUMAN PRESCRIPTION DRUG LABEL	12