FDA.reportPublic FDA data

Desvenlafaxine ER

Product NDC
72189-567
11-digit product format
721890567
Labeler code
72189
Product ID
72189-567_34f5586c-4441-54fb-e063-6394a90aa90d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine ER
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_rx
Application
ANDA204028
Marketing category
ANDA
Marketing start
2024-07-18
Substance
DESVENLAFAXINE SUCCINATE
Active strength
50 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 ER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1874559

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a9aae381-3b13-08a9-c49d-484a2c2a6dc8Product name720251106
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-567-28Desvenlafaxine ER28 in 1 BOTTLETABLET, EXTENDED RELEASE283
72189-567-30Desvenlafaxine ER30 in 1 BOTTLETABLET, EXTENDED RELEASE303
72189-567-60Desvenlafaxine ER60 in 1 BOTTLETABLET, EXTENDED RELEASE603

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-567-28EA - Each72189-56778e19cd0-89d2-4ecc-9471-15d42a927ad312024-10-04
72189-567-30EA - Each72189-56776afa022-64d7-45e3-887f-c59e00baa42712025-06-13
72189-567-60EA - Each72189-56774adde61-6b3a-453c-82e9-706e3d7c02ef12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-567DESVENLAFAXINE ER TABLET, EXTENDED RELEASE [DIRECT_RX]3Current NDC, 3 package rows20250514_1d86d1dc-d685-43aa-e063-6294a90a9907.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN1d86d1dc-d685-43aa-e063-6294a90a99073
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD1d86d1dc-d685-43aa-e063-6294a90a99073
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY1d86d1dc-d685-43aa-e063-6294a90a99073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72189-567-287218905672828 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-28) 2024-07-18NoNoHistorical
72189-567-307218905673030 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-30) 2024-07-18NoNoHistorical
72189-567-607218905676060 TABLET, EXTENDED RELEASE in 1 BOTTLE (72189-567-60) 2024-07-18NoNoHistorical