FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
42806-601
11-digit product format
428060601
Labeler code
42806
Product ID
42806-601_4bde62db-14e4-fede-e063-6294a90a1391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA214654
Marketing category
ANDA
Marketing start
2022-09-07
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
2027-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313581, 313583, 313585

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
17db3736-056c-48b9-b0f4-00fccabb14e6Product name520251118
7be8b949-f2c0-bdd8-e89d-8af92c1b2eadProduct name920250224
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-601-09Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010
42806-601-10Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100010
42806-601-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-601-09EA - Each42806-6019ae08ccd-ea8a-43e4-8632-fde07ec6901c12023-03-13
42806-601-10EA - Each42806-601c8a8eb80-c235-45de-b40f-586f13ff9e7612023-03-13
42806-601-30EA - Each42806-601ea0d85b4-de2f-419d-91c8-ba822933068012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-601VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [EPIC PHARMA, LLC]8Current NDC, Legacy NDC, 3 package rows20240621_430777f0-347c-4f21-8c5d-55f4e9897e74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNd7d1319c-500e-4ca0-83a1-a739cfa01cf7103
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDd7d1319c-500e-4ca0-83a1-a739cfa01cf7103
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYd7d1319c-500e-4ca0-83a1-a739cfa01cf7103
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN430777f0-347c-4f21-8c5d-55f4e9897e7410
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN430777f0-347c-4f21-8c5d-55f4e9897e7410
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN430777f0-347c-4f21-8c5d-55f4e9897e7410
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD430777f0-347c-4f21-8c5d-55f4e9897e7410
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD430777f0-347c-4f21-8c5d-55f4e9897e7410
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD430777f0-347c-4f21-8c5d-55f4e9897e7410
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY430777f0-347c-4f21-8c5d-55f4e9897e7410
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY430777f0-347c-4f21-8c5d-55f4e9897e7410
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY430777f0-347c-4f21-8c5d-55f4e9897e7410
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN7fcd7995-81fb-4368-bd4c-3726b2ae363e6
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD7fcd7995-81fb-4368-bd4c-3726b2ae363e6
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY7fcd7995-81fb-4368-bd4c-3726b2ae363e6
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN5a990dbd-f280-4caf-b950-4703ee98b2303
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD5a990dbd-f280-4caf-b950-4703ee98b2303
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY5a990dbd-f280-4caf-b950-4703ee98b2303
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN92b3f73d-d6ca-4d7d-9035-5700f527cb852
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNf7a9741b-2dd3-d8f3-e053-6294a90a4d732
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD92b3f73d-d6ca-4d7d-9035-5700f527cb852
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDf7a9741b-2dd3-d8f3-e053-6294a90a4d732
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY92b3f73d-d6ca-4d7d-9035-5700f527cb852
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYf7a9741b-2dd3-d8f3-e053-6294a90a4d732
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN2a85bd43-419c-6ed7-e063-6294a90a84d41
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1bf78b22-a0e3-5f9f-e063-6394a90a30241
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN2a85bd43-419c-6ed7-e063-6294a90a84d41
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD2a85bd43-419c-6ed7-e063-6294a90a84d41
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1bf78b22-a0e3-5f9f-e063-6394a90a30241
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD2a85bd43-419c-6ed7-e063-6294a90a84d41
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY2a85bd43-419c-6ed7-e063-6294a90a84d41
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1bf78b22-a0e3-5f9f-e063-6394a90a30241
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY2a85bd43-419c-6ed7-e063-6294a90a84d41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-601-094280606010990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-09) 2022-09-070000-00-00NoNoCurrent
42806-601-10428060601101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-10) 2022-09-070000-00-00NoNoCurrent
42806-601-304280606013030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-601-30) 2022-09-070000-00-00NoNoCurrent