FDA.reportPublic FDA data

Fulvestrant

Product NDC
68001-626
11-digit product format
680010626
Labeler code
68001
Product ID
68001-626_3ac255a1-c4ba-46f2-e063-6294a90a0628
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
BluePoint Laboratories.
Application
ANDA215077
Marketing category
ANDA
Marketing start
2025-01-17
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-626-85Fulvestrant2 in 1 CARTONINJECTION23
68001-626-86Fulvestrant5 mL in 1 SYRINGEINJECTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-626-85ML - Milliliter68001-6263455a8a8-a5a8-4df1-a1b7-0d56296cd5ac12025-01-14
68001-626-86ML - Milliliter68001-6267b6487cd-5392-4225-96fd-cbdca517105312025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-626FULVESTRANT INJECTION [BLUEPOINT LABORATORIES.]2Current NDC, 2 package rows20250209_57352662-d2fa-4dce-828f-4c51e46e0b4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN57352662-d2fa-4dce-828f-4c51e46e0b4d3
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD57352662-d2fa-4dce-828f-4c51e46e0b4d3
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY57352662-d2fa-4dce-828f-4c51e46e0b4d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68001-626-85680010626852 SYRINGE in 1 CARTON (68001-626-85) / 5 mL in 1 SYRINGE (68001-626-86) 2 syringe2025-01-17NoNoCurrent
68001-626-86680010626865 mL in 1 SYRINGE5 mlHistorical