FDA.reportPublic FDA data

Desvenlafaxine

Product NDC
70436-012
11-digit product format
704360012
Labeler code
70436
Product ID
70436-012_4dfe07e0-b3f0-b219-e063-6394a90aa4dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Slate Run Pharmaceuticals, LLC
Application
ANDA210014
Marketing category
ANDA
Marketing start
2020-08-01
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZB22ENF0XR
Rxcui1607617, 1874553, 1874559

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
70436-012-04Desvenlafaxine30 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE3022
70436-012-06Desvenlafaxine90 in 1 BOTTLE, PLASTICTABLET, EXTENDED RELEASE9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70436-012-04EA - Each70436-012cdaad3fe-835d-4089-9ca2-3849f5aac98d12020-08-06
70436-012-06EA - Each70436-012b44b5194-0e7c-4626-8db4-52a4175551c612020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70436-012DESVENLAFAXINE TABLET, EXTENDED RELEASE [SLATE RUN PHARMACEUTICALS, LLC]20Current NDC, Legacy NDC, 2 package rows20240617_44f4b928-d5b8-44e7-bfa6-81fb0dc1a718.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNa6c2316d-2a51-4975-a061-dc72f2724b2f106
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDa6c2316d-2a51-4975-a061-dc72f2724b2f106
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYa6c2316d-2a51-4975-a061-dc72f2724b2f106
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSN44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCD44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSY44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY44f4b928-d5b8-44e7-bfa6-81fb0dc1a71822

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70436-012-047043600120430 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-012-04) 2020-08-010000-00-00NoNoCurrent
70436-012-067043600120690 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70436-012-06) 2020-08-010000-00-00NoNoCurrent