FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
82009-058
11-digit product format
820090058
Labeler code
82009
Product ID
82009-058_b5d4c4fe-1c29-466a-9ca6-6267c7a954eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
QUALLENT PHARMACEUTICALS HEALTH LLC
Application
ANDA200834
Marketing category
ANDA
Marketing start
2022-11-21
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Venlafaxine Hydrochloride
Listing expiration
2026-12-31

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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82009-058-05Venlafaxine Hydrochloride500 in 1 BOTTLECAPSULE, EXTENDED RELEASE5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82009-058-05EA - Each82009-0581d95850f-ca20-4c1e-8153-0d851141d2c512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-058VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [QUALLENT PHARMACEUTICALS HEALTH LLC]4Current NDC, Legacy NDC, 1 package rows20240608_cb4c04a6-47d1-44ff-8d58-718102fa08eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNcb4c04a6-47d1-44ff-8d58-718102fa08eb4
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNcb4c04a6-47d1-44ff-8d58-718102fa08eb4
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNcb4c04a6-47d1-44ff-8d58-718102fa08eb4
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDcb4c04a6-47d1-44ff-8d58-718102fa08eb4
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDcb4c04a6-47d1-44ff-8d58-718102fa08eb4
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDcb4c04a6-47d1-44ff-8d58-718102fa08eb4
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYcb4c04a6-47d1-44ff-8d58-718102fa08eb4
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYcb4c04a6-47d1-44ff-8d58-718102fa08eb4
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYcb4c04a6-47d1-44ff-8d58-718102fa08eb4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82009-058-0582009005805500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82009-058-05) 2022-11-210000-00-00NoNoCurrent