FDA.reportPublic FDA data

venlafaxine hydrochloride

Product NDC
43598-001
11-digit product format
435980001
Labeler code
43598
Product ID
43598-001_646ca48a-403a-0ef0-0fc2-a5569c5b70fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
venlafaxine hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Dr.Reddys Laboratories Inc
Application
ANDA078421
Marketing category
ANDA
Marketing start
2024-09-09
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
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 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
b1435b59-059c-404b-a587-53656bf80e17Product name120230314
6005cd75-f7b1-d6be-3cb5-4bd30d5c4617Product name320190314

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-001-10venlafaxine hydrochloride1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10005
43598-001-30venlafaxine hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305
43598-001-90venlafaxine hydrochloride90 in 1 BOTTLECAPSULE, EXTENDED RELEASE905

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-001-10EA - Each43598-001e4fcdf62-dada-43d7-a2a8-e8524ccd61ea12024-12-10
43598-001-30EA - Each43598-001a2f35a1d-924e-4e01-ac90-5533ba4bbb9312024-12-10
43598-001-90EA - Each43598-0013b7596a9-107f-442d-aac2-78dba6f9912f12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-001VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [DR.REDDYS LABORATORIES INC]5Current NDC, 3 package rows20250328_f5c21429-d5d0-9f93-a465-6e5e0e19ebdd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313581venlafaxine HCl 150 MG 24HR Extended Release Oral CapsulePSNf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSNf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
313585venlafaxine HCl 75 MG 24HR Extended Release Oral CapsulePSNf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
31358124 HR venlafaxine 150 MG Extended Release Oral CapsuleSCDf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCDf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
31358524 HR venlafaxine 75 MG Extended Release Oral CapsuleSCDf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
313581venlafaxine (as venlafaxine HCl) 150 MG 24 HR Extended Release Oral CapsuleSYf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSYf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5
313585venlafaxine (as venlafaxine HCl) 75 MG 24 HR Extended Release Oral CapsuleSYf5c21429-d5d0-9f93-a465-6e5e0e19ebdd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
43598-001-10435980001101000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-10) 2024-09-09NoNoCurrent
43598-001-304359800013030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-30) 2024-09-09NoNoCurrent
43598-001-904359800019090 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43598-001-90) 2024-09-09NoNoCurrent