venlafaxine hydrochloride

Product NDC: 55111-453
11-digit product format: 551110453
Labeler code: 55111
Product ID: 55111-453_a0b75dbc-2382-70bc-7bd9-c6ef3ee4ed3e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: venlafaxine hydrochloride
Dosage form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Labeler: Dr.Reddy's Laboratories Ltd.
Application: ANDA078421
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
A078421-001	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06
A078421-002	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06
A078421-003	VENLAFAXINE HYDROCHLORIDE	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078421-001	AB
A078421-002	AB
A078421-003	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	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-002	VENLAFAXINE HYDROCHLORIDE	EQ 75MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-003	VENLAFAXINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078421-001	VENLAFAXINE HYDROCHLORIDE	EQ 37.5MG BASE	CAPSULE, EXTENDED RELEASE / ORAL	AB	2011-05-06	`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	A078421-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078421-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078421-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078421-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078421-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078421-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078421-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078421-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078421-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078421-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078421-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078421-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078421-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078421-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078421-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078421-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078421-001	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
7027be98-61d6-a986-c9df-60ceef5f7ff0	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
55111-453-01	venlafaxine hydrochloride	100 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	100	8
55111-453-05	venlafaxine hydrochloride	500 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	500	8
55111-453-30	venlafaxine hydrochloride	30 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	30	8
55111-453-60	venlafaxine hydrochloride	60 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	60	8
55111-453-78	venlafaxine hydrochloride	10 in 1 CARTON	CAPSULE, EXTENDED RELEASE	10	8
55111-453-79	venlafaxine hydrochloride	10 in 1 BLISTER PACK	CAPSULE, EXTENDED RELEASE	10	8
55111-453-90	venlafaxine hydrochloride	90 in 1 BOTTLE	CAPSULE, EXTENDED RELEASE	90	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55111-453-05	EA - Each	55111-453	8c02cd5e-58a9-479a-af6f-b7c92f5680c3	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 [DR.REDDY'S LABORATORIES LTD.]	6
VENLAFAXINE	ACTIVE MOIETY	GRZ5RCB1QG	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER	INACTIVE INGREDIENT	905HNO1SIH	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
gelatin	INACTIVE INGREDIENT	2G86QN327L	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
SHELLAC	INACTIVE INGREDIENT	46N107B71O	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
talc	INACTIVE INGREDIENT	7SEV7J4R1U	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55111-453	VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDY'S LABORATORIES LTD.]	8	Current NDC, Legacy NDC, 7 package rows	20181207_7027be98-61d6-a986-c9df-60ceef5f7ff0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr.Reddys Laboratories Inc	f5c21429-d5d0-9f93-a465-6e5e0e19ebdd	2025-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078421 application number: ANDA078421
venlafaxine hydrochloride	VENLAFAXINE HYDROCHLORIDE	Dr.Reddy's Laboratories Ltd.	7027be98-61d6-a986-c9df-60ceef5f7ff0	2018-12-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078421 application number: ANDA078421 ndc (product): 55111-453

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	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313583	venlafaxine HCl 37.5 MG 24HR Extended Release Oral Capsule	PSN	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313585	venlafaxine HCl 75 MG 24HR Extended Release Oral Capsule	PSN	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313581	24 HR venlafaxine 150 MG Extended Release Oral Capsule	SCD	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313583	24 HR venlafaxine 37.5 MG Extended Release Oral Capsule	SCD	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313585	24 HR venlafaxine 75 MG Extended Release Oral Capsule	SCD	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313581	venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral Capsule	SY	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313583	venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral Capsule	SY	7027be98-61d6-a986-c9df-60ceef5f7ff0	8
313585	venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral Capsule	SY	7027be98-61d6-a986-c9df-60ceef5f7ff0	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
55111-453-01	55111045301	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-453-01)		2011-06-01	0000-00-00	No	No	Current
55111-453-05	55111045305	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-453-05)		2011-06-01	0000-00-00	No	No	Current
55111-453-30	55111045330	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-453-30)		2011-06-01	0000-00-00	No	No	Current
55111-453-60	55111045360	60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-453-60)		2011-06-01	0000-00-00	No	No	Current
55111-453-78	55111045378	10 BLISTER PACK in 1 CARTON (55111-453-78) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (55111-453-79)	10 blister pack	2011-06-01	0000-00-00	No	No	Current
55111-453-79	55111045379	10 in 1 BLISTER PACK						Historical
55111-453-90	55111045390	90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (55111-453-90)		2011-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
venlafaxine hydrochloride	Dr.Reddy's Laboratories Ltd. \| Dr.Reddys Laboratories Limited	2018-12-06	HUMAN PRESCRIPTION DRUG LABEL	8