venlafaxine hydrochloride

Product NDC: 68071-4442
Requested package NDC: 68071-4442-9
11-digit product format: 680714442
Labeler code: 68071
Product ID: 68071-4442_1a8c4239-97e0-39ec-e063-6394a90a045b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090174
Marketing category: ANDA
Marketing start: 2011-06-01
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 150 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

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 · 3 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-4442	68071-4442-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-4442	68071-4442-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-4442	68071-4442-9	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A090174-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A090174-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A090174-003	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
A090174-001	AB
A090174-002	AB
A090174-003	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 · 126 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
2026-08-18 06:07:40	2026-07	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	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	A090174-002	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	A090174-003	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	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090174-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090174-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090174-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-001	AB	1	`1e350fbaab3a…`

Additional Listing Data#

Finished product: Yes
Brand name base: venlafaxine hydrochloride
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	150 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
313581	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
6cb943a8-5972-292f-e053-2991aa0ae3ee	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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2024-06-10	These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE capsules, for oral use Initial U.S. Approval: 1997
2023-01-30	These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE capsules, for oral use Initial U.S. Approval: 1997
2021-02-16	These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE capsules, for oral use Initial U.S. Approval: 1997
2021-01-29	These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE CAPSULES. VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE capsules, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-4442-9	venlafaxine hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-4442	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]	5	Current NDC, Legacy NDC, 1 package rows	20240612_6cb943a8-5972-292f-e053-2991aa0ae3ee.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c4312b7b-7a42-45f1-b6e6-e20ea76020c4	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	9fda0f8d-b24e-4581-9dca-7aaaf86e2413	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	de6e30f8-c8ef-4016-b228-0f188645347b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6cb943a8-5972-292f-e053-2991aa0ae3ee	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174 ndc (package): 68071-4442-9 ndc (product): 68071-4442 ndc11 (package): 68071444209
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	1be1be3a-304b-4e31-8732-335247029191	2023-09-28		Exact identifier application applno (ANDA): 090174 application number: ANDA090174
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b	2023-05-19		Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	f02cc6e8-186f-46e8-9675-70fd55d002c4	2023-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	8d6e699b-24bf-4e77-8a7f-acd496a700c7	2023-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	2022-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174

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	6cb943a8-5972-292f-e053-2991aa0ae3ee	5
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	6cb943a8-5972-292f-e053-2991aa0ae3ee	5
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	6cb943a8-5972-292f-e053-2991aa0ae3ee	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-4442-9	68071444209	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-4442-9)	2018-05-21	0000-00-00	No	No	Current