FDA.reportPublic FDA data

Venlafaxine Hydrochloride

Product NDC
68071-3638
11-digit product format
680713638
Labeler code
68071
Product ID
68071-3638_1bf78ac7-07d7-dcb7-e063-6294a90aa6cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA214654
Marketing category
ANDA
Marketing start
2022-09-07
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
37.5 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 HYDROCHLORIDE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7D7RX5A8MO
Rxcui313583

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
68071-3638-3Venlafaxine Hydrochloride30 in 1 BOTTLECAPSULE, EXTENDED RELEASE301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3638VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240630_1bf78b22-a0e3-5f9f-e063-6394a90a3024.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313583venlafaxine HCl 37.5 MG 24HR Extended Release Oral CapsulePSN1bf78b22-a0e3-5f9f-e063-6394a90a30241
31358324 HR venlafaxine 37.5 MG Extended Release Oral CapsuleSCD1bf78b22-a0e3-5f9f-e063-6394a90a30241
313583venlafaxine (as venlafaxine HCl) 37.5 MG 24 HR Extended Release Oral CapsuleSY1bf78b22-a0e3-5f9f-e063-6394a90a30241

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3638-36807136380330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (68071-3638-3) 2024-06-28NoNoCurrent