Venlafaxine Hydrochloride

Product NDC: 80425-0290
Requested package NDC: 80425-0290-3
11-digit product format: 804250290
Labeler code: 80425
Product ID: 80425-0290_2a9bad62-b303-697c-e063-6294a90aa395
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
Application: ANDA214654
Marketing category: ANDA
Marketing start: 2023-03-24
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 37.5 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: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214654-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06
A214654-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06
A214654-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214654-001	AB
A214654-002	AB
A214654-003	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 3 · 99 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	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214654-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214654-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214654-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2021-08-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 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	A214654-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214654-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214654-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214654-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214654-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214654-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214654-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214654-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214654-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214654-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214654-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214654-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214654-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214654-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214654-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214654-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214654-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214654-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214654-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214654-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214654-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214654-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214654-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214654-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214654-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214654-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214654-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214654-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214654-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214654-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214654-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214654-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214654-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214654-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214654-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214654-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214654-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214654-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214654-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214654-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Venlafaxine Hydrochloride
Brand name suffix: ER
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	37.5 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
313583	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
f7a9741b-2dd3-d8f3-e053-6294a90a4d73	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
17db3736-056c-48b9-b0f4-00fccabb14e6	Product name	5	20251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2ead	Product name	9	20250224
b1435b59-059c-404b-a587-53656bf80e17	Product name	1	20230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617	Product name	3	20190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80425-0290-1	Venlafaxine HydrochlorideER	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	2
80425-0290-2	Venlafaxine HydrochlorideER	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	2
80425-0290-3	Venlafaxine HydrochlorideER	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0290-1	EA - Each	80425-0290	8d959310-e6d9-4e6d-8b2b-e6658935aa6a	1	2023-04-07
80425-0290-2	EA - Each	80425-0290	84ab351a-50d8-4c18-8f2c-31ae6171348f	1	2023-04-07
80425-0290-3	EA - Each	80425-0290	152622f2-53b0-4e64-a257-dddf4a517ab3	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0290	VENLAFAXINE HYDROCHLORIDE ER (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	2	Current NDC, 3 package rows	20250102_f7a9741b-2dd3-d8f3-e053-6294a90a4d73.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 · 20 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS	b1d21366-f686-4e20-a10f-0c25f517db38	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	f50029b8-7d05-445a-9d9f-71a1aee6088b	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	5a990dbd-f280-4caf-b950-4703ee98b230	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	d94e5404-f728-4e4b-af99-8a8e4dfae227	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	c37a73fa-ceee-4555-a61b-e1e66ad6e97d	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	7fcd7995-81fb-4368-bd4c-3726b2ae363e	2026-06-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Epic Pharma, LLC	430777f0-347c-4f21-8c5d-55f4e9897e74	2026-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	d7d1319c-500e-4ca0-83a1-a739cfa01cf7	2026-02-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	ea5914ab-28f3-4cb3-bade-6eaccac214e4	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	bce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	0a1b6bcd-8d46-44ab-bc5d-65515601d2ff	2025-12-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	b055df74-51f9-401f-8cca-24269a0163df	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	92b3f73d-d6ca-4d7d-9035-5700f527cb85	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	33b39416-7981-46fb-ba31-e933a6afcf8b	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	963e5599-f9af-45c2-8cf4-13cf52eed6a0	2025-08-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride ER	VENLAFAXINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	f7a9741b-2dd3-d8f3-e053-6294a90a4d73	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654 ndc (package): 80425-0290-3 ndc (product): 80425-0290 ndc11 (package): 80425029003
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2a85bd43-419c-6ed7-e063-6294a90a84d4	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	1e04fe02-88c9-dafd-e063-6294a90ac4c9	2024-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	1bf78b22-a0e3-5f9f-e063-6394a90a3024	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx Pharmacy of Tennessee, LLC	19b1543e-d599-a869-e063-6294a90a8e28	2024-05-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214654 application number: ANDA214654

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE	99300-78-4	VENLAFAXINE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	f7a9741b-2dd3-d8f3-e053-6294a90a4d73	2
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	f7a9741b-2dd3-d8f3-e053-6294a90a4d73	2
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	f7a9741b-2dd3-d8f3-e053-6294a90a4d73	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80425-0290-3	80425029003	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (80425-0290-3)	2023-03-24	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine HCL ER Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	2