Venlafaxine Hydrochloride

Product NDC: 70010-184
11-digit product format: 700100184
Labeler code: 70010
Product ID: 70010-184_4f19b9ad-53a9-da61-e063-6294a90afadf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Venlafaxine Hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Granules Pharmaceuticals Inc.
Application: ANDA217390
Marketing category: ANDA
Marketing start: 2023-09-25
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A217390-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18
A217390-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18
A217390-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217390-001	AB
A217390-002	AB
A217390-003	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 2 · 72 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
2026-09-14 22:38:34	2026-08	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217390-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217390-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217390-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2023-05-18	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 72 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217390-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217390-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217390-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217390-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217390-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217390-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217390-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217390-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217390-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217390-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217390-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217390-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217390-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217390-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217390-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217390-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217390-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217390-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217390-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217390-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217390-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217390-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217390-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217390-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217390-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217390-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217390-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217390-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217390-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217390-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217390-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217390-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217390-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217390-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217390-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217390-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217390-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217390-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217390-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217390-001	AB	1	`301d65b070ca…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Venlafaxine Hydrochloride
Listing expiration: 2027-12-31

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
67059969-e291-4609-b130-0faacf2a19f0	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
70010-184-03	Venlafaxine Hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	6
70010-184-05	Venlafaxine Hydrochloride	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	6
70010-184-09	Venlafaxine Hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	6
70010-184-10	Venlafaxine Hydrochloride	1000 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	1000	6
70010-184-33	Venlafaxine Hydrochloride	15 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	15	6
70010-184-63	Venlafaxine Hydrochloride	8 in 1 CARTON	CAPSULE, EXTENDED RELEASE	8	6
70010-184-63	Venlafaxine Hydrochloride	10 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	10	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70010-184-03	EA - Each	70010-184	5c9cfd86-3bee-474e-bb74-19b2bd62c4c8	1	2024-04-05
70010-184-05	EA - Each	70010-184	0531e033-6c79-42be-a6ad-e3e6980ee04d	1	2024-04-05
70010-184-09	EA - Each	70010-184	c61d300d-83fd-44d2-8887-c63390169d3c	1	2024-04-05
70010-184-10	EA - Each	70010-184	6ee886ba-e35b-41cd-b4bd-c58cc8294f02	1	2024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70010-184	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [GRANULES PHARMACEUTICALS INC.]	4	Current NDC, 7 package rows	20240523_67059969-e291-4609-b130-0faacf2a19f0.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	7aa3edba-4248-49bb-86f7-06fdbf2a6fb7	2026-05-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	e2fa1bb0-ab86-4499-84cb-ff5e02a16991	2026-05-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	REMEDYREPACK INC.	1775b8bf-cd4f-4a8a-abd1-78d90de54fdd	2026-04-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Granules Pharmaceuticals Inc.	67059969-e291-4609-b130-0faacf2a19f0	2026-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390 ndc (product): 70010-184
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Advanced Rx of Tennessee, LLC	2a7d760c-fd9f-8026-e063-6294a90aaa43	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Coupler LLC	4a007068-89d9-c296-e063-6394a90ad6d0	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Bryant Ranch Prepack	85740bf6-7e88-4a6e-9ec9-3455e3b95e59	2026-02-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	Preferred Pharmaceuticals Inc.	15c77ad7-7edc-4c36-ba3f-3ef05dfb12dc	2025-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NuCare Pharmaceuticals Inc.	2787aaa2-5210-f7d5-e063-6294a90a7103	2024-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390
Venlafaxine Hydrochloride	VENLAFAXINE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	9c061460-3b80-41e1-a87a-1a25108ff740	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217390 application number: ANDA217390

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
313581	venlafaxine HCl 150 MG 24HR Extended Release Oral Capsule	PSN	67059969-e291-4609-b130-0faacf2a19f0	6
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	67059969-e291-4609-b130-0faacf2a19f0	6
313585	venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule	PSN	67059969-e291-4609-b130-0faacf2a19f0	6
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	67059969-e291-4609-b130-0faacf2a19f0	6
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	67059969-e291-4609-b130-0faacf2a19f0	6
313585	24 HR venlafaxine 75 MG Extended Release Oral Capsule	SCD	67059969-e291-4609-b130-0faacf2a19f0	6
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	67059969-e291-4609-b130-0faacf2a19f0	6
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	67059969-e291-4609-b130-0faacf2a19f0	6
313585	venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule	SY	67059969-e291-4609-b130-0faacf2a19f0	6
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	7aa3edba-4248-49bb-86f7-06fdbf2a6fb7	2
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	2a7d760c-fd9f-8026-e063-6294a90aaa43	2
313585	venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule	PSN	2a7d760c-fd9f-8026-e063-6294a90aaa43	2
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	2a7d760c-fd9f-8026-e063-6294a90aaa43	2
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	7aa3edba-4248-49bb-86f7-06fdbf2a6fb7	2
313585	24 HR venlafaxine 75 MG Extended Release Oral Capsule	SCD	2a7d760c-fd9f-8026-e063-6294a90aaa43	2
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	2a7d760c-fd9f-8026-e063-6294a90aaa43	2
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	7aa3edba-4248-49bb-86f7-06fdbf2a6fb7	2
313585	venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule	SY	2a7d760c-fd9f-8026-e063-6294a90aaa43	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70010-184-03	70010018403	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-184-03)		2023-09-25	No	No	Current
70010-184-05	70010018405	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-184-05)		2023-09-25	No	No	Current
70010-184-09	70010018409	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-184-09)		2023-09-25	No	No	Current
70010-184-10	70010018410	1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-184-10)		2024-05-09	No	No	Current
70010-184-33	70010018433	15 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70010-184-33)		2023-09-25	No	No	Current
70010-184-63	70010018463	8 BLISTER PACK in 1 CARTON (70010-184-63) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK	8 blister pack	2023-09-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Venlafaxine Hydrochloride	Bryant Ranch Prepack	2026-05-05	HUMAN PRESCRIPTION DRUG LABEL	2
Venlafaxine Hydrochloride	Granules Pharmaceuticals Inc. \| Granules India Limited	2026-04-10	HUMAN PRESCRIPTION DRUG LABEL	6
Venlafaxine Hydrochloride	Advanced Rx of Tennessee, LLC	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	2