FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
63629-7559
11-digit product format
636297559
Labeler code
63629
Product ID
63629-7559_fb6ebef1-ee61-4be7-ab65-3a55a7f6b644
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204003
Marketing category
ANDA
Marketing start
2017-03-01
Substance
DESVENLAFAXINE SUCCINATE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], 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
Desvenlafaxine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1874553

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-7559-1Desvenlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE30103
63629-7559-2Desvenlafaxine28 in 1 BOTTLETABLET, EXTENDED RELEASE28103
63629-7559-3Desvenlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE90103
63629-7559-4Desvenlafaxine60 in 1 BOTTLETABLET, EXTENDED RELEASE60103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-7559-3EA - Each63629-7559e976e4e1-e5cf-409e-a6e6-5ce5403fdb8712023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7559DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) TABLET, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 4 package rows20241109_c7c77c4d-dd04-4780-9fa4-8fea30aff8f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNc7c77c4d-dd04-4780-9fa4-8fea30aff8f9103
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDc7c77c4d-dd04-4780-9fa4-8fea30aff8f9103
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYc7c77c4d-dd04-4780-9fa4-8fea30aff8f9103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7559-16362975590130 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7559-1) 2018-03-190000-00-00NoNoCurrent
63629-7559-26362975590228 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7559-2) 2024-10-290000-00-00NoNoCurrent
63629-7559-36362975590390 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7559-3) 2021-08-250000-00-00NoNoCurrent
63629-7559-46362975590460 TABLET, EXTENDED RELEASE in 1 BOTTLE (63629-7559-4) 2024-10-290000-00-00NoNoCurrent