FDA.reportPublic FDA data

Savella

Product NDC
0456-1512
11-digit product format
004561512
Labeler code
0456
Product ID
0456-1512_c8829ba6-79a8-476e-8cf1-eb30641287c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
milnacipran hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Allergan, Inc.
Application
NDA022256
Marketing category
NDA
Marketing start
2009-04-17
Substance
MILNACIPRAN HYDROCHLORIDE
Active strength
12.5 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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Savella
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MILNACIPRAN HYDROCHLORIDE12.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRNZ43O5WW5
Rxcui833135, 833139, 833141, 833143, 833144, 833146, 833147, 833149, 833150, 833151

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7a197179-317f-1516-8da2-c7f3df29602aProduct name420250423
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0456-1512-11Savella10 in 1 BLISTER PACKTABLET, FILM COATED1039
0456-1512-60Savella60 in 1 BOTTLETABLET, FILM COATED6039
0456-1512-63Savella10 in 1 BOX, UNIT-DOSETABLET, FILM COATED1039

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0456-1512-60EA - Each0456-151265c821d7-e8f6-49c3-bc31-82701e550d2912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
milnacipran hydrochlorideACTIVE INGREDIENTRNZ43O5WW5SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
milnacipranACTIVE MOIETYG56VK1HF36SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
carboxymethylcellulose calciumINACTIVE INGREDIENTUTY7PDF93LSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
colloidal silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
magnesium stearateINACTIVE INGREDIENT70097M6I30SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1ASAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J990SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
povidoneINACTIVE INGREDIENTFZ989GH94ESAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
talcINACTIVE INGREDIENT7SEV7J4R1USAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [FOREST LABORATORIES, INC.]15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0456-1512SAVELLA (MILNACIPRAN HYDROCHLORIDE) TABLET, FILM COATED SAVELLA (MILNACIPRAN HYDROCHLORIDE) KIT [ALLERGAN, INC.]36Current NDC, Legacy NDC, 3 package rows20240605_16a4a314-f97e-4e91-95e9-576a3773d284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
833151{5 (milnacipran hydrochloride 12.5 MG Oral Tablet [Savella]) / 8 (milnacipran hydrochloride 25 MG Oral Tablet [Savella]) / 42 (milnacipran hydrochloride 50 MG Oral Tablet [Savella]) } Pack [Savella 4-Week Titration]BPCK16a4a314-f97e-4e91-95e9-576a3773d28439
833150{5 (milnacipran hydrochloride 12.5 MG Oral Tablet) / 8 (milnacipran hydrochloride 25 MG Oral Tablet) / 42 (milnacipran hydrochloride 50 MG Oral Tablet) } PackGPCK16a4a314-f97e-4e91-95e9-576a3773d28439
833135milnacipran HCl 100 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833141milnacipran HCl 12.5 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833150milnacipran HCl 12.5 MG Oral Tablet (5) / milnacipran HCl 25 MG Oral Tablet (8) / milnacipran HCl 50 MG Oral Tablet (42) PackPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833147milnacipran HCl 25 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833144milnacipran HCl 50 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833139Savella 100 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833143Savella 12.5 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833149Savella 25 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833151Savella 4-Week Titration PackPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833146Savella 50 MG Oral TabletPSN16a4a314-f97e-4e91-95e9-576a3773d28439
833139milnacipran hydrochloride 100 MG Oral Tablet [Savella]SBD16a4a314-f97e-4e91-95e9-576a3773d28439
833143milnacipran hydrochloride 12.5 MG Oral Tablet [Savella]SBD16a4a314-f97e-4e91-95e9-576a3773d28439
833149milnacipran hydrochloride 25 MG Oral Tablet [Savella]SBD16a4a314-f97e-4e91-95e9-576a3773d28439
833146milnacipran hydrochloride 50 MG Oral Tablet [Savella]SBD16a4a314-f97e-4e91-95e9-576a3773d28439
833135milnacipran hydrochloride 100 MG Oral TabletSCD16a4a314-f97e-4e91-95e9-576a3773d28439
833141milnacipran hydrochloride 12.5 MG Oral TabletSCD16a4a314-f97e-4e91-95e9-576a3773d28439
833147milnacipran hydrochloride 25 MG Oral TabletSCD16a4a314-f97e-4e91-95e9-576a3773d28439
833144milnacipran hydrochloride 50 MG Oral TabletSCD16a4a314-f97e-4e91-95e9-576a3773d28439
833139Savella 100 MG Oral TabletSY16a4a314-f97e-4e91-95e9-576a3773d28439
833143Savella 12.5 MG Oral TabletSY16a4a314-f97e-4e91-95e9-576a3773d28439
833149Savella 25 MG Oral TabletSY16a4a314-f97e-4e91-95e9-576a3773d28439
833151Savella 4-Week Titration PackSY16a4a314-f97e-4e91-95e9-576a3773d28439
833146Savella 50 MG Oral TabletSY16a4a314-f97e-4e91-95e9-576a3773d28439

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0456-1512-110045615121110 in 1 BLISTER PACKHistorical
0456-1512-600045615126060 TABLET, FILM COATED in 1 BOTTLE (0456-1512-60) 2009-04-170000-00-00NoNoCurrent
0456-1512-630045615126310 BLISTER PACK in 1 BOX, UNIT-DOSE (0456-1512-63) > 10 TABLET, FILM COATED in 1 BLISTER PACK (0456-1512-11) 10 blister pack2009-04-170000-00-00NoNoCurrent