Venlafaxine

Product NDC: 65862-404
11-digit product format: 658620404
Labeler code: 65862
Product ID: 65862-404_426d12db-50e2-4915-999f-84645fb387d9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA090555
Marketing category: ANDA
Marketing start: 2010-04-07
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 25 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

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090555-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07
A090555-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07
A090555-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07
A090555-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07
A090555-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A090555-001	AB
A090555-002	AB
A090555-003	AB
A090555-004	AB
A090555-005	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 6 · 205 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	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2010-04-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 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	A090555-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090555-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090555-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090555-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090555-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090555-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090555-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090555-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090555-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090555-005	AB	1	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	25 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 · 5 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313580	Internal RxNorm lookup
313582	Internal RxNorm lookup
313584	Internal RxNorm lookup
313586	Internal RxNorm lookup
314277	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
b23637e5-d37f-41b5-ba76-fc053e903bc2	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	SPL version
65862-404-01	Venlafaxine	100 in 1 BOTTLE	TABLET	100	19
65862-404-10	Venlafaxine	10 in 1 BLISTER PACK	TABLET	10	19
65862-404-10	Venlafaxine	10 in 1 CARTON	TABLET	10	19
65862-404-30	Venlafaxine	30 in 1 BOTTLE	TABLET	30	19
65862-404-60	Venlafaxine	60 in 1 BOTTLE	TABLET	60	19
65862-404-71	Venlafaxine	7000 in 1 BOTTLE	TABLET	7000	19
65862-404-90	Venlafaxine	90 in 1 BOTTLE	TABLET	90	19
65862-404-99	Venlafaxine	1000 in 1 BOTTLE	TABLET	1000	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-404-01	EA - Each	65862-404	d6800494-5918-489f-8339-9caa20032cc2	1	2012-07-24
65862-404-60	EA - Each	65862-404	183effed-e395-4a78-846d-3756efbfa0d6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
POVIDONE K30	INACTIVE INGREDIENT	U725QWY32X	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-404	VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) TABLET [AUROBINDO PHARMA LIMITED]	19	Current NDC, Legacy NDC, 8 package rows	20230823_b23637e5-d37f-41b5-ba76-fc053e903bc2.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	f56a0f70-bbb1-4e69-b969-965a72f0e2f0	2026-07-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	4a82cef5-693e-46e9-90c4-bff753cdce37	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	53e5c5a2-b8e7-3d75-e063-6294a90a508b	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	ddb51556-0292-4aa9-b781-a402c912591f	2026-02-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	b19ec628-4034-4316-ad3d-46c1ee220728	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	806b3e38-3b2a-4aaa-973c-e2d921bb353e	2026-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	f2b5c729-17c8-7ecc-e053-2a95a90a2e53	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Northwind Health Company, LLC	fb076577-b9da-c78b-e053-6394a90a107b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	304bda24-9151-47b5-9f62-005ea325a11e	2024-05-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	49e5833b-4693-45b5-9abb-1b369eb4086d	2023-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
Venlafaxine	VENLAFAXINE HYDROCHLORIDE	Aurobindo Pharma Limited	b23637e5-d37f-41b5-ba76-fc053e903bc2	2023-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555 ndc (product): 65862-404
venlafaxine	VENLAFAXINE HYDROCHLORIDE	Rising Pharma Holdings, Inc.	20319949-ccf9-477a-a6e3-53502772deb9	2023-08-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555
venlafaxine	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	5bd03cf1-e8fc-44f3-9c41-06515b897f3b	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090555 application number: ANDA090555

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
313580	venlafaxine HCl 100 MG Oral Tablet	PSN	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313582	venlafaxine HCl 25 MG Oral Tablet	PSN	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313584	venlafaxine HCl 37.5 MG Oral Tablet	PSN	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
314277	venlafaxine HCl 50 MG Oral Tablet	PSN	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313586	venlafaxine HCl 75 MG Oral Tablet	PSN	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313580	venlafaxine 100 MG Oral Tablet	SCD	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313582	venlafaxine 25 MG Oral Tablet	SCD	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313584	venlafaxine 37.5 MG Oral Tablet	SCD	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
314277	venlafaxine 50 MG Oral Tablet	SCD	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313586	venlafaxine 75 MG Oral Tablet	SCD	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313580	venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral Tablet	SY	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313582	venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral Tablet	SY	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313584	venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral Tablet	SY	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
314277	venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral Tablet	SY	b23637e5-d37f-41b5-ba76-fc053e903bc2	19
313586	venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral Tablet	SY	b23637e5-d37f-41b5-ba76-fc053e903bc2	19

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65862-404-01	65862040401	100 TABLET in 1 BOTTLE (65862-404-01)	100 tablet	2010-04-07	0000-00-00	No	No	Current
65862-404-10	65862040410	10 BLISTER PACK in 1 CARTON (65862-404-10) / 10 TABLET in 1 BLISTER PACK	10 blister pack	2010-04-07	0000-00-00	No	No	Current
65862-404-30	65862040430	30 TABLET in 1 BOTTLE (65862-404-30)	30 tablet	2010-04-07	0000-00-00	No	No	Current
65862-404-60	65862040460	60 TABLET in 1 BOTTLE (65862-404-60)	60 tablet	2010-04-07	0000-00-00	No	No	Current
65862-404-71	65862040471	7000 TABLET in 1 BOTTLE (65862-404-71)	7000 tablet	2010-04-07	0000-00-00	No	No	Current
65862-404-90	65862040490	90 TABLET in 1 BOTTLE (65862-404-90)	90 tablet	2010-04-07	0000-00-00	No	No	Current
65862-404-99	65862040499	1000 TABLET in 1 BOTTLE (65862-404-99)	1000 tablet	2010-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Tablets, USP Rx only	Aurobindo Pharma Limited	2023-08-21	Human Prescription Drug Label	19