FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
71335-2992
11-digit product format
713352992
Labeler code
71335
Product ID
71335-2992_aadedc84-bd04-4a2e-9847-476932f1756e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217390
Marketing category
ANDA
Marketing start
2023-09-25
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

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
71335-2992-1Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301
71335-2992-2Venlafaxine Hydrochloride60 in 1 BOTTLECAPSULE, EXTENDED RELEASE601
71335-2992-3Venlafaxine Hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE901
71335-2992-4Venlafaxine Hydrochloride100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSN85740bf6-7e88-4a6e-9ec9-3455e3b95e591
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCD85740bf6-7e88-4a6e-9ec9-3455e3b95e591
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSY85740bf6-7e88-4a6e-9ec9-3455e3b95e591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2992-17133529920130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2992-1) 2026-02-04NoNoHistorical
71335-2992-27133529920260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2992-2) 2026-02-04NoNoHistorical
71335-2992-37133529920390 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2992-3) 2026-02-04NoNoHistorical
71335-2992-471335299204100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-2992-4) 2026-02-04NoNoHistorical