VENLAFAXINE HYDROCHLORIDE

Product NDC: 70518-3136
Requested package NDC: 70518-3136-0
11-digit product format: 705183136
Labeler code: 70518
Product ID: 70518-3136_ea71a175-c750-cfe0-e053-2a95a90afeed
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: VENLAFAXINE HYDROCHLORIDE
Dosage form: TABLET, EXTENDED RELEASE
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA211323
Marketing category: ANDA
Marketing start: 2021-06-30
Marketing end: 0000-00-00
Substance: VENLAFAXINE HYDROCHLORIDE
Active strength: 75 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: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	70518-3136	70518-3136-0	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

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

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A211323-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29
A211323-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29
A211323-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211323-001	AB
A211323-002	AB
A211323-003	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
2026-08-18 06:07:40	2026-07	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-002	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-003	VENLAFAXINE HYDROCHLORIDE	EQ 225MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211323-001	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2019-08-29	`1e350fbaab3a…`

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
2026-08-18 06:07:40	2026-07	A211323-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211323-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211323-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211323-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211323-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211323-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211323-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211323-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211323-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211323-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211323-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211323-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211323-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211323-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211323-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211323-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211323-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211323-001	AB	1	`1e350fbaab3a…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Venlafaxine	VENLAFAXINE	Modavar Pharmaceuticals LLC	14b38374-7287-47dd-8ef9-e88bd5b23a26	2024-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211323 application number: ANDA211323
Venlafaxine	VENLAFAXINE	Cadila Pharmaceuticals Limited	516e7566-35c2-4a25-88d8-54d9dbc8f6be	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211323 application number: ANDA211323
VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	Nivagen Pharmaceuticals, Inc.	45cb4c19-fbf4-4ff5-af6f-b25a31ebc1e1	2021-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211323 application number: ANDA211323

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7D7RX5A8MO	VENLAFAXINE HYDROCHLORIDE	99300-78-4	VENLAFAXINE HYDROCHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3136-0	70518313600	90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70518-3136-0)	2021-06-30	0000-00-00	No	No	Current