FDA.reportPublic FDA data

DESVENLAFAXINE ER

Product NDC
61919-882
11-digit product format
619190882
Labeler code
61919
Product ID
61919-882_4c49ea72-e09e-fa7c-e063-6294a90aba89
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DESVENLAFAXINE ER
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Direct_Rx
Application
ANDA204172
Marketing category
ANDA
Marketing start
2019-06-04
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DESVENLAFAXINE ER
Listing expiration
2027-12-31

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
99b326f2-4886-9fc8-8686-faef7b7f27ddProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-882-28DESVENLAFAXINE ER28 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE283
61919-882-30DESVENLAFAXINE ER30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE303
61919-882-60DESVENLAFAXINE ER60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-882DESVENLAFAXINE ER TABLET, FILM COATED, EXTENDED RELEASE [DIRECT_RX]2Current NDC, Legacy NDC, 3 package rows20240111_8a834c66-846e-38a8-e053-2a95a90a4035.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN8a834c66-846e-38a8-e053-2a95a90a40353
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD8a834c66-846e-38a8-e053-2a95a90a40353
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY8a834c66-846e-38a8-e053-2a95a90a40353

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-882-286191908822828 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-882-28) 2019-06-040000-00-00NoNoCurrent
61919-882-306191908823030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-882-30) 2019-06-04NoNoCurrent
61919-882-606191908826060 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (61919-882-60) 2019-06-04NoNoCurrent