venlafaxine

Product NDC: 67046-1681
Requested package NDC: 67046-1681-3
11-digit product format: 670461681
Labeler code: 67046
Product ID: 67046-1681_53c2823f-e0da-9210-e063-6294a90a80aa
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine
Dosage form: TABLET
Route: ORAL
Labeler: Coupler LLC
Application: ANDA078932
Marketing category: ANDA
Marketing start: 2026-06-08
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA]; Serotonin Uptake Inhibitors [MoA]; Serotonin and Norepinephrine Reuptake Inhibitor [EPC]
Listing certified through: 2027-12-31
Current FDA listing: Yes

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

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
A078932-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14
A078932-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14
A078932-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14
A078932-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14
A078932-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078932-001	AB
A078932-002	AB
A078932-003	AB
A078932-004	AB
A078932-005	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 · 205 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
2026-02-19 14:30 UTC	2026-02	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-12-14	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A078932-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078932-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078932-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078932-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078932-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078932-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078932-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078932-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078932-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078932-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7D7RX5A8MO	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
314277	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
53c29dd9-a4d2-7537-e063-6294a90a290f	Available on FDA.report

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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
venlafaxine	VENLAFAXINE	Coupler LLC	53c29dd9-a4d2-7537-e063-6294a90a290f	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932 ndc (package): 67046-1681-3 ndc (product): 67046-1681 ndc11 (package): 67046168103
venlafaxine	VENLAFAXINE	St Mary's Medical Park Pharmacy	70d47b50-5722-3868-e053-2991aa0af85e	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Coupler LLC	52ce8a81-d7fc-cc97-e063-6394a90a5236	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Northwind Health Company, LLC	dabfa0f2-0060-f0ee-e053-2a95a90aec9b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Northwind Health Company, LLC	db5f1693-ca64-7a97-e053-2995a90acbff	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	REMEDYREPACK INC.	e14bfb9f-3bd2-4419-9294-9c286e79730a	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	fda14f3f-b32c-42fe-e053-6294a90a103f	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	A-S Medication Solutions	ab58f3ef-1fd3-4c68-861f-20d8fdd1b433	2024-12-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	1ce9121b-aaa0-a5bb-e063-6394a90a2f3c	2024-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Proficient Rx LP	ded77a84-e6d1-4471-ac6e-a05a0955daa5	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Proficient Rx LP	470ad045-6c82-4e44-8e88-0e2b01a41ff2	2024-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	0c9511a2-c581-44cd-bf38-a751fcc658e4	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Alembic Pharmaceuticals Inc.	67b323a7-a8c9-410f-bff0-0e515bef41a7	2023-08-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Alembic Pharmaceuticals Limited	b73da6e2-1494-436f-a204-2e4e4c5974b6	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932
venlafaxine	VENLAFAXINE	Proficient Rx LP	cc3a1258-aafb-48cf-86f7-fcf59e0c6cdd	2020-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078932 application number: ANDA078932

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	Status
67046-1681-3	67046168103	30 TABLET in 1 BLISTER PACK (67046-1681-3)	30 tablet	2026-06-08	0	Current