Venlafaxine

Product NDC: 0615-6567
Requested package NDC: 0615-6567-39
11-digit product format: 006156567
Labeler code: 0615
Product ID: 0615-6567_0f582424-6e22-4371-a052-1a4f2e48a873
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine
Dosage form: TABLET
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: ANDA077653
Marketing category: ANDA
Marketing start: 2008-06-13
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: 2027-12-31
Current FDA listing: Yes

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 · 19 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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	TE codes	Approval date
A077653-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A077653-001	AB
A077653-002	AB
A077653-003	AB
A077653-004	AB
A077653-005	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 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 220 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077653-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-004	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077653-005	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077653-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077653-005	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077653-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077653-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077653-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077653-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-005	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Venlafaxine
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	75 mg/1

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2022-09-27	VENLAFAXINE TABLETS, USP Rx only
2022-09-27	Venlafaxine Tablets, USP
2020-01-31	VENLAFAXINE TABLETS, USP Rx only
2020-01-31	Venlafaxine Tablets, USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	35

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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine	VENLAFAXINE	St. Mary's Medical Park Pharmacy	fab65158-b2f7-1db7-e053-6294a90af231	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	d4638a83-2720-430c-b529-c852aa2f7366	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	fa1db21b-98b8-3bde-e053-6394a90aa638	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	A-S Medication Solutions	7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	017a84aa-0e1f-f560-e063-6294a90a9069	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	fe7de51e-8a81-fe68-e053-6294a90a7339	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	185d90ab-1ba4-dd59-0565-e35f0fd39a2d	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	51334651-7a7f-4653-bf9d-d5be04fd902d	2024-08-14		Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	American Health Packaging	d8899628-6e1b-40c6-9bc8-553d91ae2d0c	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	1471508e-7fe4-43db-94ea-b4df1bcbafa9	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	BluePoint Laboratories	172b3d3d-bdae-47bf-8fba-edd6da1a8649	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Zydus Pharmaceuticals USA Inc.	72efad5f-0909-46a5-aa13-ac24fe015fe6	2023-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	A-S Medication Solutions	d3475ce0-1368-4961-a9b9-44c5c33cdc58	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Proficient Rx LP	b5fc0187-590c-4bb9-a910-821eb0dc1fc8	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653

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	Sample	Exclude flag	Status
0615-6567-39	00615656739	30 TABLET in 1 BLISTER PACK (0615-6567-39)	30 tablet	2026-10-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Tablets, USP	NCS HealthCare of KY, LLC dba Vangard Labs \| Zydus Pharmaceuticals USA Inc.	2026-10-27	HUMAN PRESCRIPTION DRUG LABEL	38