FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
68788-8556
11-digit product format
687888556
Labeler code
68788
Product ID
68788-8556_7307b838-12d2-4a8a-b99f-8ed1be52f6c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204172
Marketing category
ANDA
Marketing start
2023-12-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Desvenlafaxine Succinate
Listing expiration
2027-12-31

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
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
68788-8556-1Desvenlafaxine Succinate100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1004
68788-8556-3Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE304
68788-8556-6Desvenlafaxine Succinate60 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE604
68788-8556-9Desvenlafaxine Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8556-1EA - Each68788-855637b648a7-9496-40d9-a05b-086a399359ee12024-04-05
68788-8556-3EA - Each68788-855618f25793-9f19-4bbb-bdf5-e090aafdfd9212024-04-05
68788-8556-6EA - Each68788-85563b36759a-7b1b-4559-9c1b-fe2f02bbd06712024-04-05
68788-8556-9EA - Each68788-85567ab7dd02-2b44-46a0-be4d-e49fc6c9b01d12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8556DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250316_453a5759-2f0d-421d-be78-81ab97c8ce77.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN453a5759-2f0d-421d-be78-81ab97c8ce774
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD453a5759-2f0d-421d-be78-81ab97c8ce774
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY453a5759-2f0d-421d-be78-81ab97c8ce774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8556-168788855601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-1) 2023-12-06NoNoHistorical
68788-8556-36878885560330 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-3) 2023-12-06NoNoHistorical
68788-8556-66878885560660 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-6) 2023-12-06NoNoHistorical
68788-8556-96878885560990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68788-8556-9) 2023-12-06NoNoHistorical