VENLAFAXINE HYDROCHLORIDE

Product NDC: 68001-498
11-digit product format: 680010498
Labeler code: 68001
Product ID: 68001-498_2b5c3dc6-9055-abe9-e063-6294a90af76e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: BluePoint Laboratories
Application: ANDA214419
Marketing category: ANDA
Marketing start: 2021-04-30
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

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	68001-498	68001-498-05	D	Discontinued by firm		2026-08-10

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A214419-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21
A214419-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21
A214419-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21
A214419-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A214419-001	AB
A214419-002	AB
A214419-003	AB
A214419-004	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 · 144 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	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214419-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214419-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214419-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214419-004	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-21	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A214419-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214419-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214419-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214419-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214419-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214419-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214419-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214419-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214419-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214419-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214419-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214419-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214419-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214419-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214419-004	AB	1	`d06236e962d9…`

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
808744	Internal RxNorm lookup
808748	Internal RxNorm lookup
808751	Internal RxNorm lookup
808753	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
5efe1336-c796-4560-8110-a64c80eefb0c	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
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b1435b59-059c-404b-a587-53656bf80e17	Product name	1	20230314
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617	Product name	3	20190314
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68001-498-04	VENLAFAXINE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, EXTENDED RELEASE	30		7
68001-498-05	VENLAFAXINE HYDROCHLORIDE	90 in 1 BOTTLE	TABLET, EXTENDED RELEASE	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68001-498-04	EA - Each	68001-498	9c65f2ad-e082-47ed-82e7-a26159813c35	1	2021-07-15
68001-498-05	EA - Each	68001-498	9b545457-548b-41a1-827a-39b58e4fe7d8	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68001-498	VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE) TABLET, EXTENDED RELEASE [BLUEPOINT LABORATORIES]	7	Current NDC, Legacy NDC, 2 package rows	20250112_5efe1336-c796-4560-8110-a64c80eefb0c.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	BluePoint Laboratories	5efe1336-c796-4560-8110-a64c80eefb0c	2025-01-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214419 application number: ANDA214419 ndc (product): 68001-498
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	XLCare Pharmaceuticals, Inc.	68f40801-d35e-464e-ac94-21016b617ea2	2021-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214419 application number: ANDA214419
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE	Camber Pharmaceuticals, Inc.	8c4ccc5c-f6a2-4ce3-8866-9e6b32b08fd3	2021-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214419 application number: ANDA214419

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE	99300-78-4	VENLAFAXINE HYDROCHLORIDE
GRZ5RCB1QG	VENLAFAXINE	93413-69-5	venlafaxine

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	5efe1336-c796-4560-8110-a64c80eefb0c	7
808748	venlafaxine HCl 225 MG 24HR Extended Release Oral Tablet	PSN	5efe1336-c796-4560-8110-a64c80eefb0c	7
808751	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Tablet	PSN	5efe1336-c796-4560-8110-a64c80eefb0c	7
808753	venlafaxine HCl 75 MG 24HR Extended Release Oral Tablet	PSN	5efe1336-c796-4560-8110-a64c80eefb0c	7
808744	24 HR venlafaxine 150 MG Extended Release Oral Tablet	SCD	5efe1336-c796-4560-8110-a64c80eefb0c	7
808748	24 HR venlafaxine 225 MG Extended Release Oral Tablet	SCD	5efe1336-c796-4560-8110-a64c80eefb0c	7
808751	24 HR venlafaxine 37.5 MG Extended Release Oral Tablet	SCD	5efe1336-c796-4560-8110-a64c80eefb0c	7
808753	24 HR venlafaxine 75 MG Extended Release Oral Tablet	SCD	5efe1336-c796-4560-8110-a64c80eefb0c	7
808744	venlafaxine 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808744	venlafaxine 150 MG 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808748	venlafaxine 225 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808748	venlafaxine 225 MG 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808751	venlafaxine 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808751	venlafaxine 37.5 MG 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808753	venlafaxine 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7
808753	venlafaxine 75 MG 24 HR Extended Release Oral Tablet	SY	5efe1336-c796-4560-8110-a64c80eefb0c	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68001-498-04	68001049804	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-498-04)	2021-04-30	0000-00-00	No	No	Current
68001-498-05	68001049805	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-498-05)	2021-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VENLAFAXINE HYDROCHLORIDE	BluePoint Laboratories \| Ascent Pharmaceuticals, Inc.	2025-01-10	HUMAN PRESCRIPTION DRUG LABEL	7