Venlafaxine Hydrochloride

Product NDC: 43353-798
Requested package NDC: 43353-798-60
11-digit product format: 433530798
Labeler code: 43353
Product ID: 43353-798_ad3a32db-8ab9-402e-a263-33931bc29cd1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA079098
Marketing category: ANDA
Marketing start: 2012-05-07
Marketing end: 0000-00-00
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: 2022-12-31
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	43353-798	43353-798-60	D	Discontinued by firm		2026-10-05

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	43353-798	43353-798-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-798	43353-798-60	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079098-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079098-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079098-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079098-004	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079098-005	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079098-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079098-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079098-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079098-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A079098-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079098-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079098-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079098-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079098-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079098-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079098-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079098-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079098-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079098-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A079098-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079098-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079098-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079098-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079098-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A079098-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079098-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079098-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079098-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079098-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A079098-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079098-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079098-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079098-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079098-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A079098-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079098-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079098-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079098-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079098-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A079098-005	AB	1	`782e0a99824c…`

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
43353-798-53	EA - Each	43353-798	91811fe5-8790-41d8-bd64-f0b4c82bcde5	1	2014-06-03
43353-798-60	EA - Each	43353-798	b03fcd89-0ad2-40d2-aa0f-3cc3dbc7bac6	1	2021-04-08
43353-798-70	EA - Each	43353-798	e051629e-82de-40c7-b8a3-8cf9037db327	1	2014-08-01
43353-798-80	EA - Each	43353-798	4c3102cc-e7be-4f36-a782-0dc7f9b61c1b	1	2014-06-03
43353-798-84	EA - Each	43353-798	2de05842-e905-4f94-a4ea-201d8066b5ae	1	2014-08-01
43353-798-88	EA - Each	43353-798	e2e1585a-f2a0-466f-91e0-5ac687246257	1	2014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-798	VENLAFAXINE HYDROCHLORIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	4	Legacy NDC	20210323_4146cf6f-4181-49e1-9f59-3ba280f60ced.zip

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43353-798-60	43353079860	90 TABLET in 1 BOTTLE, PLASTIC (43353-798-60)	90 tablet	2021-02-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride Tablets 25 mg, 37.5 mg, 75mg, and 100 mg	Aphena Pharma Solutions - Tennessee, LLC	2021-03-22	HUMAN PRESCRIPTION DRUG LABEL	4