FDA.reportPublic FDA data

Fulvestrant

Product NDC
71288-555
11-digit product format
712880555
Labeler code
71288
Product ID
71288-555_2be67b09-31de-41b4-9468-a73a284abe41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Meitheal Pharmaceuticals Inc
Application
ANDA209714
Marketing category
ANDA
Marketing start
2019-11-21
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Fulvestrant

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
71288-555-85Fulvestrant5 mL in 1 SYRINGEINJECTION56
71288-555-86Fulvestrant2 in 1 CARTONINJECTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-555-85ML - Milliliter71288-5556a06f7cf-58c0-4e49-9dbc-5ba7f4ecdf7612020-04-20
71288-555-86ML - Milliliter71288-555e51717b6-15ef-4752-9c6c-215256f8356012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-555FULVESTRANT INJECTION [MEITHEAL PHARMACEUTICALS INC]6Current NDC, Legacy NDC, 2 package rows20240627_015fafb6-23f7-4566-9c23-386eee7b035d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN015fafb6-23f7-4566-9c23-386eee7b035d6
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD015fafb6-23f7-4566-9c23-386eee7b035d6
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY015fafb6-23f7-4566-9c23-386eee7b035d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-555-85712880555855 mL in 1 SYRINGE5 mlHistorical
71288-555-86712880555862 SYRINGE in 1 CARTON (71288-555-86) / 5 mL in 1 SYRINGE (71288-555-85) 2 syringe2019-11-212027-01-31NoNoCurrent