FDA.reportPublic FDA data

Desvenlafaxine Succinate

Product NDC
68180-592
11-digit product format
681800592
Labeler code
68180
Product ID
68180-592_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
2017-03-01
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
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 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
68180-592-02Desvenlafaxine Succinate500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50023
68180-592-06Desvenlafaxine Succinate30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3023
68180-592-09Desvenlafaxine 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
68180-592-06EA - Each68180-592cfb2aae7-d2c3-4935-a576-fd128d62e2d112017-04-05
68180-592-09EA - Each68180-592f826a628-d7ed-49e0-8a42-fd91782f0b7012017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-592DESVENLAFAXINE 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
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN593d340b-f49a-455b-aeb2-5a1eaf7b6cbe9
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD593d340b-f49a-455b-aeb2-5a1eaf7b6cbe9
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY593d340b-f49a-455b-aeb2-5a1eaf7b6cbe9
1874559desvenlafaxine succinate 50 MG 24HR Extended Release Oral TabletPSN5755f1b2-c10b-47f6-a08d-38d1c05bd3534
187455924 HR desvenlafaxine succinate 50 MG Extended Release Oral TabletSCD5755f1b2-c10b-47f6-a08d-38d1c05bd3534
1874559desvenlafaxine 50 MG (as desvenlafaxine succinate 76 MG) 24HR Extended Release Oral TabletSY5755f1b2-c10b-47f6-a08d-38d1c05bd3534
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
68180-592-0268180059202500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-02) 2017-03-010000-00-00NoNoCurrent
68180-592-066818005920630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-06) 2017-03-010000-00-00NoNoCurrent
68180-592-096818005920990 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-592-09) 2017-03-010000-00-00NoNoCurrent