Effexor

Product NDC
58151-126
11-digit product format
581510126
Labeler code
58151
Product ID
58151-126_2319042f-5d24-42d3-9b0a-8893bed66813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VENLAFAXINE HYDROCHLORIDE
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Viatris Specialty LLC
Application
NDA020699
Marketing category
NDA
Marketing start
2024-10-30
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 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020699-001EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20
N020699-002EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20
N020699-003EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1997-10-20
N020699-004EFFEXOR XRVENLAFAXINE HYDROCHLORIDEEQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020699-001AB
N020699-002AB
N020699-004AB

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 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N020699-003EFFEXOR XREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1997-10-2084e616aacf4f…
2026-09-14 22:38:342026-08N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-2084e616aacf4f…
2026-08-18 06:07:402026-07N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020699-003EFFEXOR XREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1997-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-003EFFEXOR XREQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**CAPSULE, EXTENDED RELEASE / ORALRLD1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-001EFFEXOR XREQ 37.5MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-002EFFEXOR XREQ 75MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-003EFFEXOR XREQ 100MG BASECAPSULE, EXTENDED RELEASE / ORAL1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-004EFFEXOR XREQ 150MG BASECAPSULE, EXTENDED RELEASE / ORALABRLD, RS1997-10-205bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N020699-001AB184e616aacf4f…
2026-09-14 22:38:342026-08N020699-002AB184e616aacf4f…
2026-09-14 22:38:342026-08N020699-004AB184e616aacf4f…
2026-08-18 06:07:402026-07N020699-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020699-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07N020699-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020699-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020699-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020699-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020699-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020699-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020699-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020699-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020699-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020699-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020699-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020699-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020699-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10N020699-004AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020699-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020699-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020699-004AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020699-001AB1301d65b070ca…

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
Effexor
Brand name suffix
XR
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VENLAFAXINE HYDROCHLORIDE75 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 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313581Internal RxNorm lookup
313583Internal RxNorm lookup
313585Internal RxNorm lookup
729929Internal RxNorm lookup
729931Internal RxNorm lookup
729932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c848a5d8-ba94-4c84-80e3-0bf35fb8e32eAvailable 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
58151-126-77EffexorXR90 in 1 BOTTLECAPSULE, EXTENDED RELEASE907
58151-126-93EffexorXR30 in 1 BOTTLECAPSULE, EXTENDED RELEASE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58151-126-77EA - Each58151-126304d0564-3a5f-4560-b1d4-55b26caba95612024-11-05
58151-126-93EA - Each58151-1262be9dbfa-8711-4fe8-884e-4bae41a96faa12024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-126EFFEXOR XR (VENLAFAXINE HYDROCHLORIDE) CAPSULE, EXTENDED RELEASE [VIATRIS SPECIALTY LLC]6Current NDC, 2 package rows20241101_c848a5d8-ba94-4c84-80e3-0bf35fb8e32e.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
Effexor XRVENLAFAXINE HYDROCHLORIDEViatris Specialty LLCc848a5d8-ba94-4c84-80e3-0bf35fb8e32e2023-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020699
application number: NDA020699
ndc (product): 58151-126

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
729931Effexor XR 150 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729932Effexor XR 37.5 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729929Effexor XR 75 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993124 HR venlafaxine 150 MG Extended Release Oral Capsule [Effexor]SBDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993224 HR venlafaxine 37.5 MG Extended Release Oral Capsule [Effexor]SBDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72992924 HR venlafaxine 75 MG Extended Release Oral Capsule [Effexor]SBDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993124 HR Effexor 150 MG Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72993224 HR Effexor 37.5 MG Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
72992924 HR Effexor 75 MG Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729931Effexor XR 150 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729931Effexor XR 150 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729932Effexor XR 37.5 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729932Effexor XR 37.5 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729929Effexor XR 75 MG (as venlafaxine hydrochloride) 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
729929Effexor XR 75 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYc848a5d8-ba94-4c84-80e3-0bf35fb8e32e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58151-126-775815101267790 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-126-77) 2024-10-30NoNoCurrent
58151-126-935815101269330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (58151-126-93) 2024-10-30NoNoCurrent