Venlafaxine

Product NDC: 68382-018
11-digit product format: 683820018
Labeler code: 68382
Product ID: 68382-018_ea404f6c-7e07-4779-a52c-8cffb92718ef
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine
Dosage form: TABLET
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA077653
Marketing category: ANDA
Marketing start: 2008-06-13
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
A077653-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13
A077653-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077653-001	AB
A077653-002	AB
A077653-003	AB
A077653-004	AB
A077653-005	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	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2008-06-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2008-06-13	`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	A077653-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077653-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077653-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077653-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077653-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077653-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077653-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077653-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077653-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077653-005	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
72efad5f-0909-46a5-aa13-ac24fe015fe6	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
68382-018-01	Venlafaxine	100 in 1 BOTTLE	TABLET	100	19
68382-018-05	Venlafaxine	500 in 1 BOTTLE	TABLET	500	19
68382-018-06	Venlafaxine	30 in 1 BOTTLE	TABLET	30	19
68382-018-10	Venlafaxine	1000 in 1 BOTTLE	TABLET	1000	19
68382-018-14	Venlafaxine	60 in 1 BOTTLE	TABLET	60	19
68382-018-16	Venlafaxine	90 in 1 BOTTLE	TABLET	90	19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-018-01	EA - Each	68382-018	386dd560-6153-4f0f-a3ae-b046935be3de	1	2012-07-24
68382-018-10	EA - Each	68382-018	514c67ac-dac6-455e-8be9-34707c17ce57	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]	8
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	VENLAFAXINE HYDROCHLORIDE TABLET [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-018	VENLAFAXINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]	19	Current NDC, Legacy NDC, 6 package rows	20230829_72efad5f-0909-46a5-aa13-ac24fe015fe6.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 · 14 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine	VENLAFAXINE	St. Mary's Medical Park Pharmacy	fab65158-b2f7-1db7-e053-6294a90af231	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	d4638a83-2720-430c-b529-c852aa2f7366	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	fa1db21b-98b8-3bde-e053-6394a90aa638	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	A-S Medication Solutions	7bbdc9c5-a4b9-44d4-babc-46bd8c2e084a	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	017a84aa-0e1f-f560-e063-6294a90a9069	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	NuCare Pharmaceuticals,Inc.	fe7de51e-8a81-fe68-e053-6294a90a7339	2025-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	185d90ab-1ba4-dd59-0565-e35f0fd39a2d	2024-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	51334651-7a7f-4653-bf9d-d5be04fd902d	2024-08-14		Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	American Health Packaging	d8899628-6e1b-40c6-9bc8-553d91ae2d0c	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Bryant Ranch Prepack	1471508e-7fe4-43db-94ea-b4df1bcbafa9	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	BluePoint Laboratories	172b3d3d-bdae-47bf-8fba-edd6da1a8649	2023-08-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Zydus Pharmaceuticals USA Inc.	72efad5f-0909-46a5-aa13-ac24fe015fe6	2023-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653 ndc (product): 68382-018
Venlafaxine	VENLAFAXINE	A-S Medication Solutions	d3475ce0-1368-4961-a9b9-44c5c33cdc58	2023-05-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653
Venlafaxine	VENLAFAXINE	Proficient Rx LP	b5fc0187-590c-4bb9-a910-821eb0dc1fc8	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077653 application number: ANDA077653

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
313580	venlafaxine HCl 100 MG Oral Tablet	PSN	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313582	venlafaxine HCl 25 MG Oral Tablet	PSN	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313584	venlafaxine HCl 37.5 MG Oral Tablet	PSN	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
314277	venlafaxine HCl 50 MG Oral Tablet	PSN	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313586	venlafaxine HCl 75 MG Oral Tablet	PSN	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313580	venlafaxine 100 MG Oral Tablet	SCD	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313582	venlafaxine 25 MG Oral Tablet	SCD	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313584	venlafaxine 37.5 MG Oral Tablet	SCD	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
314277	venlafaxine 50 MG Oral Tablet	SCD	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313586	venlafaxine 75 MG Oral Tablet	SCD	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313580	venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral Tablet	SY	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313582	venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral Tablet	SY	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313584	venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral Tablet	SY	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
314277	venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral Tablet	SY	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313586	venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral Tablet	SY	72efad5f-0909-46a5-aa13-ac24fe015fe6	19
313580	venlafaxine HCl 100 MG Oral Tablet	PSN	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313582	venlafaxine HCl 25 MG Oral Tablet	PSN	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313586	venlafaxine HCl 75 MG Oral Tablet	PSN	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313580	venlafaxine 100 MG Oral Tablet	SCD	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313582	venlafaxine 25 MG Oral Tablet	SCD	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313586	venlafaxine 75 MG Oral Tablet	SCD	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313580	venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral Tablet	SY	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313582	venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral Tablet	SY	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1
313586	venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral Tablet	SY	a4e1d3bc-4e97-4ff0-9e30-22a699c96072	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-018-01	68382001801	100 TABLET in 1 BOTTLE (68382-018-01)	100 tablet	2008-06-13	0000-00-00	No	No	Current
68382-018-05	68382001805	500 TABLET in 1 BOTTLE (68382-018-05)	500 tablet	2008-06-13	0000-00-00	No	No	Current
68382-018-06	68382001806	30 TABLET in 1 BOTTLE (68382-018-06)	30 tablet	2008-06-13	0000-00-00	No	No	Current
68382-018-10	68382001810	1000 TABLET in 1 BOTTLE (68382-018-10)	1000 tablet	2008-06-13	0000-00-00	No	No	Current
68382-018-14	68382001814	60 TABLET in 1 BOTTLE (68382-018-14)	60 tablet	2008-06-13	0000-00-00	No	No	Current
68382-018-16	68382001816	90 TABLET in 1 BOTTLE (68382-018-16)	90 tablet	2008-06-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Tablets, USP	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2023-08-26	HUMAN PRESCRIPTION DRUG LABEL	19
Venlafaxine Hydrochloride Tablets	Rebel Distributors Corp	2011-12-13	HUMAN PRESCRIPTION DRUG LABEL	1