FDA.reportPublic FDA data

Osphena

Product NDC
55494-580
11-digit product format
554940580
Labeler code
55494
Product ID
55494-580_2e1f0dd2-9e5b-413e-e063-6294a90a636a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ospemifene
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Duchesnay USA, Inc.
Application
NDA203505
Marketing category
NDA
Marketing start
2023-04-01
Substance
OSPEMIFENE
Active strength
60 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OSPEMIFENE60 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB0P231ILBK
Rxcui1370976, 1370982

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b80a7030-e2ec-3276-1476-f6b2292284acProduct name220250116

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55494-580-18Osphena15 in 1 BLISTER PACKTABLET, FILM COATED154
55494-580-18Osphena1 in 1 PACKAGETABLET, FILM COATED14
55494-580-30Osphena30 in 1 BOTTLETABLET, FILM COATED304
55494-580-55Osphena1 in 1 PACKAGETABLET, FILM COATED14
55494-580-55Osphena5 in 1 BLISTER PACKTABLET, FILM COATED54
55494-580-90Osphena90 in 1 BOTTLETABLET, FILM COATED904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55494-580-90EA - Each55494-580f85f1d9d-bff5-4525-94ff-c3f1885c248512023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55494-580OSPHENA (OSPEMIFENE) TABLET, FILM COATED [DUCHESNAY USA, INC.]4Current NDC, 6 package rows20250216_9accbcc9-78ee-4f84-9b7e-704f2ab1c413.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1370976ospemifene 60 MG Oral TabletPSN9accbcc9-78ee-4f84-9b7e-704f2ab1c4134
1370982Osphena 60 MG Oral TabletPSN9accbcc9-78ee-4f84-9b7e-704f2ab1c4134
1370982ospemifene 60 MG Oral Tablet [Osphena]SBD9accbcc9-78ee-4f84-9b7e-704f2ab1c4134
1370976ospemifene 60 MG Oral TabletSCD9accbcc9-78ee-4f84-9b7e-704f2ab1c4134
1370982Osphena 60 MG Oral TabletSY9accbcc9-78ee-4f84-9b7e-704f2ab1c4134

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55494-580-18554940580181 BLISTER PACK in 1 PACKAGE (55494-580-18) / 15 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-04-01YesNoCurrent
55494-580-305549405803030 TABLET, FILM COATED in 1 BOTTLE (55494-580-30) 2023-08-01NoNoCurrent
55494-580-55554940580551 BLISTER PACK in 1 PACKAGE (55494-580-55) / 5 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-04-01YesNoCurrent
55494-580-905549405809090 TABLET, FILM COATED in 1 BOTTLE (55494-580-90) 2023-04-01NoNoCurrent