Venlafaxine Hydrochloride

Product NDC: 65162-307
11-digit product format: 651620307
Labeler code: 65162
Product ID: 65162-307_e3157b1f-11f7-4682-8129-07482e1626df
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA079098
Marketing category: ANDA
Marketing start: 2010-05-11
Marketing end: 0000-00-00
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 75 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: 2023-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	65162-307		D	Discontinued by firm		2026-10-15
excluded package	package	65162-307	65162-307-09	D	Discontinued by firm		2026-10-15

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A079098-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2010-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079098-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	2010-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079098-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	2010-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079098-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	2010-05-11	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A079098-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2010-05-11	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 140 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079098-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079098-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079098-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079098-004	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079098-005	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079098-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079098-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079098-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079098-004	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A079098-005	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079098-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A079098-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A079098-003	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A079098-004	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A079098-005	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079098-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079098-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079098-003	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079098-004	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079098-005	AB	1	`cb3db0bc1861…`

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
65162-307-09	EA - Each	65162-307	1607203b-3755-45f9-a6d0-999de3481c1e	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 (VENLAFAXINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	14
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]	14
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
Anhydrous Lactose	INACTIVE INGREDIENT	3SY5LH9PMK	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
Cellulose, Microcrystalline	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
Ferric Oxide Red	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
Ferric Oxide Yellow	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4
Sodium Starch Glycolate Type A Potato	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE HYDROCHLORIDE TABLET [AVKARE, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-307	VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET [AMNEAL PHARMACEUTICALS LLC]	27	Legacy NDC	20241031_62c02cdb-ea65-41ff-a531-4d9ea498f705.zip

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
65162-307-09	65162030709	90 TABLET in 1 BOTTLE (65162-307-09)	90 tablet	2010-05-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Tablets, USP (25 mg, 37.5 mg, 50 mg, 75 mg and 100 mg) Rx only	Amneal Pharmaceuticals LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	27
Venlafaxine Tablets, USP Rx only	AvPAK	2022-01-18	HUMAN PRESCRIPTION DRUG LABEL	8
Venlafaxine Tablets, USP Rx only	AvKARE	2022-01-17	HUMAN PRESCRIPTION DRUG LABEL	9