Venlafaxine Hydrochloride

Product NDC: 29033-046
Requested package NDC: 29033-046-30
11-digit product format: 290330046
Labeler code: 29033
Product ID: 29033-046_11ed7ee6-1687-4eab-88fd-22fee419a846
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: Nostrum Laboratories, Inc.
Application: ANDA205468
Marketing category: ANDA
Marketing start: 2017-03-27
Marketing end: 0000-00-00
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 225 mg/1
Pharmacologic classes: Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	29033-046	29033-046-30	I	Inactivated by FDA		2026-10-05

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A205468-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-24
A205468-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2017-03-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A205468-002	AB
A205468-003	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 · 86 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
2026-09-14 22:38:34	2026-08	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205468-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205468-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2017-03-24	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A205468-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205468-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205468-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205468-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205468-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205468-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205468-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205468-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205468-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205468-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205468-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205468-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205468-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205468-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205468-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205468-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205468-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205468-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205468-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205468-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205468-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205468-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205468-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205468-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205468-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205468-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205468-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205468-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205468-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205468-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205468-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205468-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205468-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205468-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205468-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205468-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205468-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205468-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205468-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205468-003	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

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#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
29033-046-30	2026-01-29	C162847	48780-1	49896155-accb-586f-e063-e6dba90add90	These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. VENLAFAXINE HYDROCHLORIDE extended-release tablets for oral use Initial U.S. Approval: 1993
29033-046-90	2026-01-29	C162847	48780-1	49896155-accb-586f-e063-e6dba90add90	These highlights do not include all the information needed to use VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for VENLAFAXINE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. VENLAFAXINE HYDROCHLORIDE extended-release tablets for oral use Initial U.S. Approval: 1993

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
29033-046-30	Venlafaxine Hydrochloride	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		5
29033-046-90	Venlafaxine Hydrochloride	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
29033-046-30	EA - Each	29033-046	d8ba313a-26b2-4a07-bfcd-d97588b50a14	1	2017-04-05
29033-046-90	EA - Each	29033-046	86f8a849-5261-47a3-8627-023ee8b2fa74	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
29033-046	VENLAFAXINE HYDROCHLORIDE TABLET, EXTENDED RELEASE [NOSTRUM LABORATORIES, INC.]	5	Legacy NDC, 2 package rows	20210610_b84c7126-9216-4f35-ace4-156a493e2b2d.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Westminster Pharmaceuticals, LLC	349308ef-2caf-4fec-b428-56ae06c6771d	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205468 application number: ANDA205468

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
808744	venlafaxine HCl 150 MG 24HR Extended Release Oral Tablet	PSN	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808748	venlafaxine HCl 225 MG 24HR Extended Release Oral Tablet	PSN	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808744	24 HR venlafaxine 150 MG Extended Release Oral Tablet	SCD	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808748	24 HR venlafaxine 225 MG Extended Release Oral Tablet	SCD	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808744	venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808744	venlafaxine 150 MG 24 HR Extended Release Oral Tablet	SY	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808748	venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	b84c7126-9216-4f35-ace4-156a493e2b2d	5
808748	venlafaxine 225 MG 24 HR Extended Release Oral Tablet	SY	b84c7126-9216-4f35-ace4-156a493e2b2d	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
29033-046-30	29033004630	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (29033-046-30)	2017-03-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride	Golden State Medical Supply	2023-08-15	HUMAN PRESCRIPTION DRUG LABEL	5
Venlafaxine Hydrochloride	Nostrum Laboratories, Inc.	2018-01-01	HUMAN PRESCRIPTION DRUG LABEL	5