FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
42806-602
11-digit product format
428060602
Labeler code
42806
Product ID
42806-602_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
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
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 HYDROCHLORIDE75 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
42806-602-09Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010
42806-602-10Venlafaxine Hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE100010
42806-602-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-602-09EA - Each42806-6025d4ead97-3218-482a-afb0-0c47c6cd220112023-03-13
42806-602-10EA - Each42806-6025f3ab956-754b-408a-b8fd-1cfe0903d4de12023-03-13
42806-602-30EA - Each42806-602a863f920-19a9-46b1-8e64-26c6e332236712023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-602VENLAFAXINE 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
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
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN33b39416-7981-46fb-ba31-e933a6afcf8b3
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD33b39416-7981-46fb-ba31-e933a6afcf8b3
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY33b39416-7981-46fb-ba31-e933a6afcf8b3
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNea5914ab-28f3-4cb3-bade-6eaccac214e42
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNb055df74-51f9-401f-8cca-24269a0163df2
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDea5914ab-28f3-4cb3-bade-6eaccac214e42
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDb055df74-51f9-401f-8cca-24269a0163df2
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYea5914ab-28f3-4cb3-bade-6eaccac214e42
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYb055df74-51f9-401f-8cca-24269a0163df2
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN2a85bd43-419c-6ed7-e063-6294a90a84d41
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNd94e5404-f728-4e4b-af99-8a8e4dfae2271
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN2a85bd43-419c-6ed7-e063-6294a90a84d41
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf50029b8-7d05-445a-9d9f-71a1aee6088b1
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN1e04fe02-88c9-dafd-e063-6294a90ac4c91
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSN19b1543e-d599-a869-e063-6294a90a8e281
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD2a85bd43-419c-6ed7-e063-6294a90a84d41
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDd94e5404-f728-4e4b-af99-8a8e4dfae2271
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf50029b8-7d05-445a-9d9f-71a1aee6088b1
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD19b1543e-d599-a869-e063-6294a90a8e281
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD2a85bd43-419c-6ed7-e063-6294a90a84d41
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCD1e04fe02-88c9-dafd-e063-6294a90ac4c91
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY2a85bd43-419c-6ed7-e063-6294a90a84d41
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY2a85bd43-419c-6ed7-e063-6294a90a84d41
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYd94e5404-f728-4e4b-af99-8a8e4dfae2271
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY1e04fe02-88c9-dafd-e063-6294a90ac4c91
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSY19b1543e-d599-a869-e063-6294a90a8e281
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf50029b8-7d05-445a-9d9f-71a1aee6088b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-602-094280606020990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-602-09) 2022-09-070000-00-00NoNoCurrent
42806-602-10428060602101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-602-10) 2022-09-070000-00-00NoNoCurrent
42806-602-304280606023030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-602-30) 2022-09-070000-00-00NoNoCurrent