VENLAFAXINE

Product NDC: 71209-028
11-digit product format: 712090028
Labeler code: 71209
Product ID: 71209-028_f6bcbdd6-db09-4aeb-8eb0-6eadb8ebdeba
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine
Dosage form: TABLET
Route: ORAL
Labeler: Cadila Pharmaceuticals Limited
Application: ANDA206250
Marketing category: ANDA
Marketing start: 2018-12-03
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: 2026-12-31
Current FDA listing: Yes

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

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
A206250-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-004	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21
A206250-005	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206250-001	AB
A206250-002	AB
A206250-003	AB
A206250-004	AB
A206250-005	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 · 210 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	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-001	VENLAFAXINE HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-002	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-003	VENLAFAXINE HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-004	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-005	VENLAFAXINE HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2018-11-21	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A206250-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206250-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206250-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206250-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206250-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206250-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206250-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206250-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206250-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206250-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206250-005	AB	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
VENLAFAXINE HYDROCHLORIDE	75 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
2ed61dcf-42e3-47cf-a607-459eef5fea98	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	Strength	SPL version
71209-028-05	VENLAFAXINE	100 in 1 BOTTLE	TABLET	100		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71209-028	VENLAFAXINE TABLET [CADILA PHARMACEUTICALS LIMITED]	8	Current NDC, Legacy NDC, 1 package rows	20231230_2ed61dcf-42e3-47cf-a607-459eef5fea98.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
VENLAFAXINE	VENLAFAXINE	Cadila Pharmaceuticals Limited	2ed61dcf-42e3-47cf-a607-459eef5fea98	2023-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206250 application number: ANDA206250 ndc (product): 71209-028

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	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313582	venlafaxine HCl 25 MG Oral Tablet	PSN	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313584	venlafaxine HCl 37.5 MG Oral Tablet	PSN	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
314277	venlafaxine HCl 50 MG Oral Tablet	PSN	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313586	venlafaxine HCl 75 MG Oral Tablet	PSN	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313580	venlafaxine 100 MG Oral Tablet	SCD	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313582	venlafaxine 25 MG Oral Tablet	SCD	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313584	venlafaxine 37.5 MG Oral Tablet	SCD	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
314277	venlafaxine 50 MG Oral Tablet	SCD	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313586	venlafaxine 75 MG Oral Tablet	SCD	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313580	venlafaxine 100 MG (as venlafaxine hydrochloride 113 MG) Oral Tablet	SY	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313582	venlafaxine 25 MG (as venlafaxine hydrochloride 28.3 MG) Oral Tablet	SY	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313584	venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral Tablet	SY	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
314277	venlafaxine 50 MG (as venlafaxine hydrochloride 56.6 MG) Oral Tablet	SY	2ed61dcf-42e3-47cf-a607-459eef5fea98	8
313586	venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral Tablet	SY	2ed61dcf-42e3-47cf-a607-459eef5fea98	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71209-028-05	71209002805	100 TABLET in 1 BOTTLE (71209-028-05)	100 tablet	2018-12-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
VENLAFAXINE TABLETS, USP Rx only	Cadila Pharmaceuticals Limited	2023-08-01	Human Prescription Drug Label	8