Venlafaxine Hydrochloride

Product NDC: 76420-630
11-digit product format: 764200630
Labeler code: 76420
Product ID: 76420-630_51d1cf0b-ea69-e7ff-e063-6294a90ad233
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA200834
Marketing category: ANDA
Marketing start: 2011-06-01
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: 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A200834-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A200834-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A200834-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200834-001	AB
A200834-002	AB
A200834-003	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 4 · 123 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	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200834-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A200834-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200834-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200834-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200834-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200834-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200834-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200834-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200834-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200834-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200834-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200834-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200834-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200834-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200834-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200834-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200834-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200834-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 38 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	4e3053b9-cdec-4f4d-85ae-2e55cf1cc185	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	50d3b487-9f65-4e2f-b6eb-9533964f8972	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ac9b972d-8b8a-4727-90c2-b208f91272fd	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	5358f20f-b864-0aae-e063-6394a90a7eab	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	5359012e-a868-3aa3-e063-6294a90a74e2	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Asclemed USA, Inc.	c69d16fd-b82d-4708-aece-ab4f60b29cc6	2026-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834 ndc (product): 76420-630
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	7852be9e-0c1d-47a8-9513-c3a04b365763	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	28c8f404-1dbd-4140-8959-32624d7c7724	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	296d6ab7-8c0c-40e5-8cb2-9d125b42b8bb	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Cardinal Health 107, LLC	7588ffdc-034d-4baf-9889-9a0ded265be5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	33068acd-d361-4cd9-b994-02a7865ff04f	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	812ca864-8230-4c84-a7f4-d1b926dee31a	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	569e10d1-6432-473c-a026-ac438bd77bcd	2026-03-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine HCL ER	VENLAFAXINE HCL ER	Direct_Rx	f32ca617-66e0-41d8-e053-2a95a90ae40a	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	QPharma, Inc.	4992698e-5d5a-6468-e063-6394a90ab404	2026-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	e2d5a2d5-5e55-426c-bc8d-d29729eba775	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	f757cac4-efa7-668c-e053-6294a90a720d	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Major Pharmaceuticals	d962f5af-7642-4c6e-b7be-3e089fe48873	2025-10-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	22980b32-cbae-4f37-9fc0-b47221b2c32e	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	0c404290-2806-4756-bca3-2d639b400963	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200834 application number: ANDA200834

Additional Listing Data#

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

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313581	Internal RxNorm lookup
313583	Internal RxNorm lookup
313585	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
c69d16fd-b82d-4708-aece-ab4f60b29cc6	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
76420-630-01	Venlafaxine Hydrochloride	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	3
76420-630-15	Venlafaxine Hydrochloride	15 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	15	3
76420-630-30	Venlafaxine Hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	3
76420-630-60	Venlafaxine Hydrochloride	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	3
76420-630-90	Venlafaxine Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-630	VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [ASCLEMED USA, INC.]	2	Current NDC, 5 package rows	20250227_c69d16fd-b82d-4708-aece-ab4f60b29cc6.zip

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
313581	venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule	PSN	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313585	venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule	PSN	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313585	24 HR venlafaxine 75 MG Extended Release Oral Capsule	SCD	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3
313585	venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule	SY	c69d16fd-b82d-4708-aece-ab4f60b29cc6	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
76420-630-01	76420063001	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-01)	2023-10-18	No	No	Current
76420-630-15	76420063015	15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-15)	2023-10-18	No	No	Current
76420-630-30	76420063030	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-30)	2023-10-18	No	No	Current
76420-630-60	76420063060	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-60)	2023-10-18	No	No	Current
76420-630-90	76420063090	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (76420-630-90)	2023-10-18	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-05-14	HUMAN PRESCRIPTION DRUG LABEL	3