FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
42806-603
11-digit product format
428060603
Labeler code
42806
Product ID
42806-603_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
150 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 HYDROCHLORIDE150 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
42806-603-05Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE50010
42806-603-09Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE9010
42806-603-30Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-603-05EA - Each42806-60377b53807-bf07-44d5-9f2f-bcefeabf9e2712023-03-13
42806-603-09EA - Each42806-603a3d38d3d-56f5-4413-9c8e-0f58b3114a3012023-03-13
42806-603-30EA - Each42806-603cae95dbc-b1f4-48a4-8e73-b3d0d762bedd12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-603VENLAFAXINE 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
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN0a1b6bcd-8d46-44ab-bc5d-65515601d2ff3
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNc37a73fa-ceee-4555-a61b-e1e66ad6e97d3
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN963e5599-f9af-45c2-8cf4-13cf52eed6a03
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD963e5599-f9af-45c2-8cf4-13cf52eed6a03
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD0a1b6bcd-8d46-44ab-bc5d-65515601d2ff3
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDc37a73fa-ceee-4555-a61b-e1e66ad6e97d3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY963e5599-f9af-45c2-8cf4-13cf52eed6a03
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY0a1b6bcd-8d46-44ab-bc5d-65515601d2ff3
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYc37a73fa-ceee-4555-a61b-e1e66ad6e97d3
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYbce7adf8-b4b5-4d7f-bf0d-ae1277ae3a2b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-603-0542806060305500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-603-05) 2022-09-070000-00-00NoNoCurrent
42806-603-094280606030990 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-603-09) 2022-09-070000-00-00NoNoCurrent
42806-603-304280606033030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42806-603-30) 2022-09-070000-00-00NoNoCurrent