Venlafaxine hydrochloride

Product NDC
33342-194
11-digit product format
333420194
Labeler code
33342
Product ID
33342-194_ea9c3795-420f-49fb-918c-7033a1f06963
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204889
Marketing category
ANDA
Marketing start
2017-10-06
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204889-001VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05
A204889-002VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05
A204889-003VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A204889-001AB
A204889-002AB
A204889-003AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-052680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-055bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05d06236e962d9…
2024-10-29 15:01 UTC2024-10A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204889-002VENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-051e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204889-003VENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204889-001VENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALAB2017-10-058072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204889-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204889-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204889-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204889-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204889-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204889-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204889-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204889-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204889-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204889-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204889-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204889-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204889-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204889-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204889-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204889-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204889-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204889-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204889-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204889-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204889-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204889-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204889-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204889-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204889-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204889-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204889-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204889-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204889-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204889-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204889-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204889-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204889-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204889-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204889-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204889-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204889-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204889-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204889-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204889-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7D7RX5A8MOInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313581Internal RxNorm lookup
313583Internal RxNorm lookup
313585Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e51f786-3691-4ec4-836b-7f2c9a385aa7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-194-07Venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307
33342-194-10Venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907
33342-194-11Venlafaxine hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1007
33342-194-12Venlafaxine hydrochloride10 in 1 CARTONCAPSULE, EXTENDED RELEASE107
33342-194-12Venlafaxine hydrochloride10 in 1 BLISTER PACKCAPSULE, EXTENDED RELEASE107
33342-194-15Venlafaxine hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-194-07EA - Each33342-194dc527543-040f-4f98-822b-d2b03538af4b12018-07-03
33342-194-10EA - Each33342-194fd23028d-61f8-4b56-8886-6128923b35d312021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-194VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 6 package rows20230921_3e51f786-3691-4ec4-836b-7f2c9a385aa7.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Venlafaxine hydrochlorideVENLAFAXINE HYDROCHLORIDEMacleods Pharmaceuticals Limited3e51f786-3691-4ec4-836b-7f2c9a385aa72026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204889
application number: ANDA204889
ndc (product): 33342-194

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN3e51f786-3691-4ec4-836b-7f2c9a385aa77
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN3e51f786-3691-4ec4-836b-7f2c9a385aa77
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN3e51f786-3691-4ec4-836b-7f2c9a385aa77
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD3e51f786-3691-4ec4-836b-7f2c9a385aa77
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD3e51f786-3691-4ec4-836b-7f2c9a385aa77
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD3e51f786-3691-4ec4-836b-7f2c9a385aa77
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY3e51f786-3691-4ec4-836b-7f2c9a385aa77
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY3e51f786-3691-4ec4-836b-7f2c9a385aa77
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY3e51f786-3691-4ec4-836b-7f2c9a385aa77
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN63ece9a0-6692-4af7-b86a-f06ac52441b71
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD63ece9a0-6692-4af7-b86a-f06ac52441b71
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY63ece9a0-6692-4af7-b86a-f06ac52441b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-194-073334201940730 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-07) 2017-10-060000-00-00NoNoCurrent
33342-194-103334201941090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-10) 2018-08-140000-00-00NoNoCurrent
33342-194-1133342019411100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-11) 2018-08-140000-00-00NoNoCurrent
33342-194-123334201941210 BLISTER PACK in 1 CARTON (33342-194-12) / 10 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK10 blister pack2017-10-060000-00-00NoNoCurrent
33342-194-1533342019415500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (33342-194-15) 2017-10-060000-00-00NoNoCurrent