venlafaxine hydrochloride

Product NDC: 68382-034
11-digit product format: 683820034
Labeler code: 68382
Product ID: 68382-034_8c02c121-fe14-45f5-b2bc-b09fd377531f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA090174
Marketing category: ANDA
Marketing start: 2011-06-01
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 37.5 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090174-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A090174-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14
A090174-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A090174-001	AB
A090174-002	AB
A090174-003	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 · 123 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	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090174-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-04-14	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A090174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090174-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090174-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090174-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090174-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090174-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090174-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090174-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090174-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090174-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090174-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090174-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090174-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090174-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090174-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090174-001	AB	1	`8072bd15b7f6…`

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	37.5 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313581	Internal RxNorm lookup
313583	Internal RxNorm lookup
313585	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
5351fe67-17d9-42ec-9e8b-6585fdb9e29e	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
68382-034-06	venlafaxine hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	16
68382-034-10	venlafaxine hydrochloride	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	16
68382-034-16	venlafaxine hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-034-06	EA - Each	68382-034	23a505a3-4127-4d0d-861f-87dcf22af3f4	1	2012-07-24
68382-034-10	EA - Each	68382-034	b3d8db48-89bb-4b23-b29d-0ac430ff17e0	1	2012-07-24
68382-034-16	EA - Each	68382-034	ced389b3-c4e6-4650-b57b-5c4d46541847	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
GELATIN	INACTIVE INGREDIENT	2G86QN327L	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS (USA) INC.]	6
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [TYA PHARMACEUTICALS]	4
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
VENLAFAXINE HYDROCHLORIDE	ACTIVE INGREDIENT	7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)	INACTIVE INGREDIENT	P2OM2Q86BI	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
ETHYLCELLULOSE (100 MPA.S)	INACTIVE INGREDIENT	47MLB0F1MV	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
POWDERED CELLULOSE	INACTIVE INGREDIENT	SMD1X3XO9M	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DIRECT RX]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-034	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 3 package rows	20221023_5351fe67-17d9-42ec-9e8b-6585fdb9e29e.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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	c4312b7b-7a42-45f1-b6e6-e20ea76020c4	2026-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	9fda0f8d-b24e-4581-9dca-7aaaf86e2413	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	de6e30f8-c8ef-4016-b228-0f188645347b	2025-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	6cb943a8-5972-292f-e053-2991aa0ae3ee	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	1be1be3a-304b-4e31-8732-335247029191	2023-09-28		Exact identifier application applno (ANDA): 090174 application number: ANDA090174
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Lifesciences Limited	1349bace-d2cb-4c8f-8cbd-c09e67a2ca1b	2023-05-19		Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	f02cc6e8-186f-46e8-9675-70fd55d002c4	2023-03-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	A-S Medication Solutions	8d6e699b-24bf-4e77-8a7f-acd496a700c7	2023-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Zydus Pharmaceuticals USA Inc.	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	2022-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090174 application number: ANDA090174 ndc (product): 68382-034

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
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	b49a550b-cd80-4e24-9ae9-52d362e36bdf	18
313585	venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule	PSN	b49a550b-cd80-4e24-9ae9-52d362e36bdf	18
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	b49a550b-cd80-4e24-9ae9-52d362e36bdf	18
313585	24 HR venlafaxine 75 MG Extended Release Oral Capsule	SCD	b49a550b-cd80-4e24-9ae9-52d362e36bdf	18
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	b49a550b-cd80-4e24-9ae9-52d362e36bdf	18
313585	venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule	SY	b49a550b-cd80-4e24-9ae9-52d362e36bdf	18
313581	venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule	PSN	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313585	venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule	PSN	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313585	24 HR venlafaxine 75 MG Extended Release Oral Capsule	SCD	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313585	venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule	SY	5351fe67-17d9-42ec-9e8b-6585fdb9e29e	16
313581	venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule	PSN	01d6c49d-f831-44dc-bd59-dc93ebdeee2f	4
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	01d6c49d-f831-44dc-bd59-dc93ebdeee2f	4
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	8d6e699b-24bf-4e77-8a7f-acd496a700c7	4
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	01d6c49d-f831-44dc-bd59-dc93ebdeee2f	4
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	8d6e699b-24bf-4e77-8a7f-acd496a700c7	4
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	01d6c49d-f831-44dc-bd59-dc93ebdeee2f	4
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	01d6c49d-f831-44dc-bd59-dc93ebdeee2f	4
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	8d6e699b-24bf-4e77-8a7f-acd496a700c7	4
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	01d6c49d-f831-44dc-bd59-dc93ebdeee2f	4
313581	venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule	PSN	3cfc589e-455e-4df3-91e6-6cfece5c420a	3
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	3cfc589e-455e-4df3-91e6-6cfece5c420a	3
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	3cfc589e-455e-4df3-91e6-6cfece5c420a	3
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	3cfc589e-455e-4df3-91e6-6cfece5c420a	3
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	3cfc589e-455e-4df3-91e6-6cfece5c420a	3
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	3cfc589e-455e-4df3-91e6-6cfece5c420a	3
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	908dc8d9-6c94-0c40-e053-2a95a90a2e57	1
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	908dc8d9-6c94-0c40-e053-2a95a90a2e57	1
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	908dc8d9-6c94-0c40-e053-2a95a90a2e57	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-034-06	68382003406	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-06)	2011-06-01	0000-00-00	No	No	Current
68382-034-10	68382003410	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-10)	2011-06-01	0000-00-00	No	No	Current
68382-034-16	68382003416	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68382-034-16)	2011-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
venlafaxine hydrochloride	Major Pharmaceuticals	2024-12-09	HUMAN PRESCRIPTION DRUG LABEL	4
venlafaxine hydrochloride	REMEDYREPACK INC.	2024-01-05	HUMAN PRESCRIPTION DRUG LABEL	13
venlafaxine hydrochloride	A-S Medication Solutions	2023-01-05	HUMAN PRESCRIPTION DRUG LABEL	4
venlafaxine hydrochloride	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2022-10-21	HUMAN PRESCRIPTION DRUG LABEL	16
venlafaxine hydrochloride	Preferred Pharmaceuticals Inc.	2022-10-19	HUMAN PRESCRIPTION DRUG LABEL	6
venlafaxine hydrochloride	Bryant Ranch Prepack	2022-02-09	HUMAN PRESCRIPTION DRUG LABEL	100
venlafaxine hydrochloride	A-S Medication Solutions	2021-08-07	HUMAN PRESCRIPTION DRUG LABEL	18
venlafaxine hydrochloride	NuCare Pharmaceuticals,Inc.	2021-02-15	HUMAN PRESCRIPTION DRUG LABEL	5
VENLAFAXINE HYDROCHLORIDE	Direct_Rx	2019-08-20	HUMAN PRESCRIPTION DRUG LABEL	1
Venlafaxine Hydrochloride Extended-release Capsules	Lake Erie Medical DBA Quality Care Products LLC	2019-05-30	HUMAN PRESCRIPTION DRUG LABEL	2
VENLAFAXINE HYDROCHLORIDE	DIRECT RX	2019-04-24	HUMAN PRESCRIPTION DRUG LABEL	3
Venlafaxine Hydrochloride Extended-release Capsules, USP	TYA Pharmaceuticals	2014-07-11	HUMAN PRESCRIPTION DRUG LABEL	4