venlafaxine hydrochloride, extended release

Product NDC: 42799-963
11-digit product format: 427990963
Labeler code: 42799
Product ID: 42799-963_a7958920-40c7-4038-8524-3f830555d345
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride, extended release
Dosage form: TABLET
Route: ORAL
Labeler: Edenbridge Pharmaceuticals LLC.
Application: ANDA209193
Marketing category: ANDA
Marketing start: 2023-03-15
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: 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 · 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: venlafaxine hydrochloride, extended release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	225 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
808744	Internal RxNorm lookup
808748	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
38431a76-6185-4c17-994f-8278b6cd7510	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	Strength	SPL version
42799-963-01	venlafaxine hydrochloride, extended release	30 in 1 BOTTLE	TABLET	30		4
42799-963-02	venlafaxine hydrochloride, extended release	90 in 1 BOTTLE	TABLET	90		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42799-963-01	EA - Each	42799-963	c2ae1b0d-1526-4767-a4ab-2d2d6dff9bf7	1	2023-06-06
42799-963-02	EA - Each	42799-963	90e0bef8-7ac8-4f9b-97ad-84de14b349eb	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42799-963	VENLAFAXINE HYDROCHLORIDE, EXTENDED RELEASE TABLET [EDENBRIDGE PHARMACEUTICALS LLC.]	3	Current NDC, 2 package rows	20240105_38431a76-6185-4c17-994f-8278b6cd7510.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 ndc (product): 42799-963
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

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	38431a76-6185-4c17-994f-8278b6cd7510	4
808748	venlafaxine HCl 225 MG 24HR Extended Release Oral Tablet	PSN	38431a76-6185-4c17-994f-8278b6cd7510	4
808744	24 HR venlafaxine 150 MG Extended Release Oral Tablet	SCD	38431a76-6185-4c17-994f-8278b6cd7510	4
808748	24 HR venlafaxine 225 MG Extended Release Oral Tablet	SCD	38431a76-6185-4c17-994f-8278b6cd7510	4
808744	venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	38431a76-6185-4c17-994f-8278b6cd7510	4
808744	venlafaxine 150 MG 24 HR Extended Release Oral Tablet	SY	38431a76-6185-4c17-994f-8278b6cd7510	4
808748	venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	38431a76-6185-4c17-994f-8278b6cd7510	4
808748	venlafaxine 225 MG 24 HR Extended Release Oral Tablet	SY	38431a76-6185-4c17-994f-8278b6cd7510	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42799-963-01	42799096301	30 TABLET in 1 BOTTLE (42799-963-01)	30 tablet	2023-03-15	No	No	Current
42799-963-02	42799096302	90 TABLET in 1 BOTTLE (42799-963-02)	90 tablet	2023-03-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
venlafaxine hydrochloride, extended release	Edenbridge Pharmaceuticals LLC.	2026-01-08	Human Prescription Drug Label	4