FDA.reportPublic FDA data

Savella

Product NDC
55154-4626
11-digit product format
551544626
Labeler code
55154
Product ID
55154-4626_29696af7-4f76-41f7-b2b0-c766bd7b21ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
milnacipran hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
NDA022256
Marketing category
NDA
Marketing start
2009-04-17
Substance
MILNACIPRAN HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
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
Savella
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILNACIPRAN HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRNZ43O5WW5
Rxcui833144, 833146

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a197179-317f-1516-8da2-c7f3df29602aProduct name420250423

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4626-8Savella1920 in 1 BOTTLETABLET, FILM COATED192011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
milnacipran hydrochlorideACTIVE INGREDIENTRNZ43O5WW5SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
milnacipranACTIVE MOIETYG56VK1HF36SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
magnesium stearateINACTIVE INGREDIENT70097M6I30SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ASAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ESAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
talcINACTIVE INGREDIENT7SEV7J4R1USAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4626SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]10Current NDC, Legacy NDC, 1 package rows20250309_8b720a1e-034b-4583-b80d-105a794cce74.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833144milnacipran HCl 50 MG Oral TabletPSN8b720a1e-034b-4583-b80d-105a794cce7411
833146Savella 50 MG Oral TabletPSN8b720a1e-034b-4583-b80d-105a794cce7411
833146milnacipran hydrochloride 50 MG Oral Tablet [Savella]SBD8b720a1e-034b-4583-b80d-105a794cce7411
833144milnacipran hydrochloride 50 MG Oral TabletSCD8b720a1e-034b-4583-b80d-105a794cce7411
833146Savella 50 MG Oral TabletSY8b720a1e-034b-4583-b80d-105a794cce7411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55154-4626-8551544626081920 TABLET, FILM COATED in 1 BOTTLE (55154-4626-8) 2009-04-170000-00-00NoNoCurrent