Venlafaxine Hydrochloride

Product NDC: 0527-2605
Requested package NDC: 0527-2605-46
11-digit product format: 005272605
Labeler code: 0527
Product ID: 0527-2605_22da933d-33b2-43fa-b30f-bc0e599e99ac
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Lannett Company, Inc.
Application: ANDA209193
Marketing category: ANDA
Marketing start: 2019-12-26
Marketing end: 0000-00-00
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 225 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: 2023-12-31
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	0527-2605	0527-2605-46	D	Discontinued by firm		2026-08-03

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 · 1 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	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0527-2605	0527-2605-46	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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

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
A209193-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-10-31
A209193-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB		2019-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209193-001	AB
A209193-002	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 2 · 78 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	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209193-001	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209193-002	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 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	A209193-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209193-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209193-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209193-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209193-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209193-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209193-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209193-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209193-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209193-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209193-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209193-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209193-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209193-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209193-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209193-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209193-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209193-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209193-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209193-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209193-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209193-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209193-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209193-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209193-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209193-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209193-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209193-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209193-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209193-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209193-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209193-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209193-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209193-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209193-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209193-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209193-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209193-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209193-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209193-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0527-2605-32	EA - Each	0527-2605	08e0c578-ecdb-4f08-888e-a816db890fe0	1	2020-01-03
0527-2605-46	EA - Each	0527-2605	80d173ab-a7e7-4d46-9903-72a886d1abd3	1	2020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0527-2605	VENLAFAXINE HYDROCHLORIDE TABLET [LANNETT COMPANY, INC.]	7	Legacy NDC	20220209_eda2cf78-3369-4463-b297-62c7edaa1314.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
venlafaxine hydrochloride, extended release	VENLAFAXINE HYDROCHLORIDE, EXTENDED RELEASE	Edenbridge Pharmaceuticals LLC.	38431a76-6185-4c17-994f-8278b6cd7510	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209193 application number: ANDA209193
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Chartwell RX, LLC	85ec2d3f-49e4-4ac5-bd4a-c227589dbf58	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209193 application number: ANDA209193

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0527-2605-46	00527260546	90 TABLET in 1 BOTTLE (0527-2605-46)	90 tablet	2019-12-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride	Bryant Ranch Prepack	2024-01-12	HUMAN PRESCRIPTION DRUG LABEL	101
Venlafaxine Hydrochloride	Bryant Ranch Prepack	2023-02-20	HUMAN PRESCRIPTION DRUG LABEL	103
Venlafaxine Hydrochloride	Lannett Company, Inc.	2021-10-31	HUMAN PRESCRIPTION DRUG LABEL	7