Venlafaxine Hydrochloride

Product NDC: 68025-081
11-digit product format: 680250081
Labeler code: 68025
Product ID: 68025-081_499e9472-5d08-4d56-8dbc-f1a4b632631e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Vertical Pharmaceuticals, LLC
Application: NDA022104
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2010-04-29
Marketing end: 2026-05-31
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
NDC exclude flag: No
Current FDA listing: Yes

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	68025-081		D	Discontinued by firm		2026-08-10
excluded package	package	68025-081	68025-081-30	D	Discontinued by firm		2026-08-10

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022104-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20
N022104-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20
N022104-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20
N022104-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N022104-001	AB
N022104-002	AB
N022104-003	AB
N022104-004	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 5 · 164 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	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022104-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022104-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022104-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2008-05-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022104-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2008-05-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	N022104-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022104-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022104-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022104-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022104-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022104-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022104-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022104-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022104-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022104-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022104-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022104-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022104-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022104-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022104-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022104-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022104-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022104-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022104-004	AB	1	`d06236e962d9…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
17db3736-056c-48b9-b0f4-00fccabb14e6	Product name	5	20251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2ead	Product name	9	20250224
b1435b59-059c-404b-a587-53656bf80e17	Product name	1	20230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617	Product name	3	20190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68025-081-30	Venlafaxine Hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68025-081-30	EA - Each	68025-081	28780117-ed66-40d6-8087-2d1f3cbb9059	1	2016-12-07
68025-081-90	EA - Each	68025-081	d05197da-23a3-41fe-acc5-c642bb976ef6	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68025-081	VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [VERTICAL PHARMACEUTICALS, LLC]	15	Current NDC, Legacy NDC, 1 package rows	20240719_82872e90-4f86-49f7-9f38-39c0f75e4467.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Trigen Laboratories, LLC	fdaed1c2-dd0a-4bf3-975a-86fe3e7f0c97	2025-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022104 application number: NDA022104
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2cf6e6ad-7d00-0db1-e063-6394a90ab1ec	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022104 application number: NDA022104

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68025-081-30	68025008130	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-081-30)	2010-04-29	2026-05-31	No	No	Current
68025-081-90	68025008190	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68025-081-90)	2010-04-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride	Vertical Pharmaceuticals, LLC	2023-08-30	HUMAN PRESCRIPTION DRUG LABEL	15