FDA.reportPublic FDA data

Fulvestrant

Product NDC
0781-3532
11-digit product format
007813532
Labeler code
0781
Product ID
0781-3532_99e95543-2f0d-4992-80ff-00a4f92d6e06
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sandoz Inc
Application
ANDA205935
Marketing category
ANDA
Marketing start
2023-11-01
Substance
FULVESTRANT
Active strength
50 mg/mL
Pharmacologic classes
Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], 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
Fulvestrant
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
FULVESTRANT50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii22X328QOC4
Rxcui727762

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a809a83e-b49f-c569-2b4b-23ba590406b3Product name820240208
15aad051-0f67-42b5-934c-5fc8a73abadeProduct name120200213
3e4adb99-b829-4f50-ab9b-1e9b483563f6Product name120190821
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-3532-01Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION52
0781-3532-12Fulvestrant2 in 1 CARTONINJECTION22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-3532-01ML - Milliliter0781-35321334ec3e-c6f2-407b-90a2-fb8d9fa7d32a12024-01-04
0781-3532-12ML - Milliliter0781-3532e1d70d8d-4e24-4077-b4ac-7748513ff77712024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-3532FULVESTRANT INJECTION [SANDOZ INC]2Current NDC, 2 package rows20240925_141f439e-078c-4a59-acff-ebf7685f55b8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN141f439e-078c-4a59-acff-ebf7685f55b82
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD141f439e-078c-4a59-acff-ebf7685f55b82
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY141f439e-078c-4a59-acff-ebf7685f55b82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0781-3532-01007813532015 mL in 1 SYRINGE, GLASS5 mlHistorical
0781-3532-12007813532122 SYRINGE, GLASS in 1 CARTON (0781-3532-12) / 5 mL in 1 SYRINGE, GLASS (0781-3532-01) 2023-11-01NoNoHistorical