Desvenlafaxine Succinate

Product NDC
68180-604
11-digit product format
681800604
Labeler code
68180
Product ID
68180-604_748a4941-405f-436f-933b-0bec4b119e3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Desvenlafaxine Succinate
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA204172
Marketing category
ANDA
Marketing start
2022-08-25
Substance
DESVENLAFAXINE SUCCINATE
Active strength
25 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 Succinate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DESVENLAFAXINE SUCCINATE25 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
68180-604-02Desvenlafaxine Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50023
68180-604-06Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3023
68180-604-09Desvenlafaxine Succinate90 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-604-06EA - Each68180-604121fedf2-81f6-44fe-9af9-db4a1f2aa55912022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-604DESVENLAFAXINE SUCCINATE TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 3 package rows20250510_e96272a2-8f73-4fbe-a8d4-a78d4ad68831.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1874553desvenlafaxine succinate 100 MG 24HR Extended Release Oral TabletPSNe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSNe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSNe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
187455324 HR desvenlafaxine succinate 100 MG Extended Release Oral TabletSCDe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCDe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCDe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
1874553desvenlafaxine 100 MG (as desvenlafaxine succinate 152 MG) 24HR Extended Release Oral TabletSYe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSYe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSYe96272a2-8f73-4fbe-a8d4-a78d4ad6883123
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN5f349cc5-b803-462d-b323-d681bd1a02f02
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD5f349cc5-b803-462d-b323-d681bd1a02f02
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY5f349cc5-b803-462d-b323-d681bd1a02f02
1607617desvenlafaxine succinate 25 MG 24HR Extended Release Oral TabletPSN7ee04e8c-ce6c-450d-9122-2bffd170bfd71
160761724 HR desvenlafaxine succinate 25 MG Extended Release Oral TabletSCD7ee04e8c-ce6c-450d-9122-2bffd170bfd71
1607617desvenlafaxine 25 MG (as desvenlafaxine succinate 38 MG) 24HR Extended Release Oral TabletSY7ee04e8c-ce6c-450d-9122-2bffd170bfd71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-604-0268180060402500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-604-02) 2022-06-300000-00-00NoNoCurrent
68180-604-066818006040630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-604-06) 2022-08-250000-00-00NoNoCurrent
68180-604-096818006040990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-604-09) 2022-06-300000-00-00NoNoCurrent