Venlafaxine Hydrochloride

Product NDC: 71610-013
Requested package NDC: 71610-013-79
11-digit product format: 716100013
Labeler code: 71610
Product ID: 71610-013_f112c189-5a07-46a6-b27a-34f5f6da9a47
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VENLAFAXINE HYDROCHLORIDE
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA020699
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2011-06-02
Marketing end: 0000-00-00
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 150 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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71610-013	71610-013-79	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71610-013	71610-013-79	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71610-013	71610-013-79	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
N020699-001	EFFEXOR XR	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20
N020699-002	EFFEXOR XR	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20
N020699-003	EFFEXOR XR	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1997-10-20
N020699-004	EFFEXOR XR	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N020699-001	AB
N020699-002	AB
N020699-004	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	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020699-003	EFFEXOR XR	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE, EXTENDED RELEASE / ORAL		RLD	1997-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020699-001	EFFEXOR XR	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020699-002	EFFEXOR XR	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD	1997-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020699-003	EFFEXOR XR	EQ 100MG BASE	CAPSULE, EXTENDED RELEASE / ORAL			1997-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020699-004	EFFEXOR XR	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	RLD, RS	1997-10-20	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	N020699-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020699-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020699-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020699-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020699-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020699-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020699-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020699-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020699-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020699-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020699-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020699-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020699-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020699-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020699-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020699-004	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020699-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020699-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020699-004	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020699-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020699-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020699-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020699-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020699-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020699-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020699-001	AB	1	`8072bd15b7f6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71610-013-53	EA - Each	71610-013	27b44270-2daf-45d7-b0ec-662f24217352	1	2018-03-08
71610-013-79	EA - Each	71610-013	fb6940e6-54ff-47a8-b21e-e38f28bcf6d4	1	2018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71610-013	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2	Legacy NDC	20190409_385d063a-970a-4e54-a99e-42271cfa861d.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
Effexor XR	VENLAFAXINE HYDROCHLORIDE	Viatris Specialty LLC	c848a5d8-ba94-4c84-80e3-0bf35fb8e32e	2023-08-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020699 application number: NDA020699

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
71610-013-79	71610001379	2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71610-013-79)	2017-12-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride	Aphena Pharma Solutions - Tennessee, LLC	2019-04-05	HUMAN PRESCRIPTION DRUG LABEL	2