FDA.reportPublic FDA data

Venlafaxine

Product NDC
61919-617
11-digit product format
619190617
Labeler code
61919
Product ID
61919-617_87e71680-68de-7a37-e053-2a95a90af7f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Venlafaxine
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA078932
Marketing category
ANDA
Marketing start
2019-04-24
Marketing end
0000-00-00
Substance
VENLAFAXINE HYDROCHLORIDE
Active strength
38 mg/1
Pharmacologic classes
Norepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-617-302025-01-31C16284748780-1f386c64a-346c-0266-e053-dadaa90a7c1aVENLAFAXINE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-617-30Venlafaxine30 in 1 BOTTLETABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-617-30EA - Each61919-617507e68c5-6692-4989-a292-175087af7cab12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-617VENLAFAXINE TABLET VENLAFAXINE TABLET [DIRECT RX]9Legacy NDC, 1 package rows20230411_5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313584venlafaxine HCl 37.5 MG Oral TabletPSN5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f9
313586venlafaxine HCl 75 MG Oral TabletPSN5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f9
313584venlafaxine 37.5 MG Oral TabletSCD5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f9
313586venlafaxine 75 MG Oral TabletSCD5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f9
313584venlafaxine 37.5 MG (as venlafaxine hydrochloride 42.5 MG) Oral TabletSY5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f9
313586venlafaxine 75 MG (as venlafaxine hydrochloride 84.9 MG) Oral TabletSY5cdfdcb3-eaa5-63b9-e053-2a91aa0ae17f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-617-306191906173030 in 1 BOTTLEHistorical