FDA.reportPublic FDA data

FULVESTRANT

Product NDC
68001-522
11-digit product format
680010522
Labeler code
68001
Product ID
68001-522_e4b34fb8-f651-8d00-e053-2995a90a3d2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
BluePoint Laboratories
Application
ANDA211689
Marketing category
ANDA
Marketing start
2021-10-29
Substance
FULVESTRANT
Active strength
250 mg/5mL
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
FULVESTRANT250 mg/5mL

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68001-522-85FULVESTRANT2 in 1 CARTONINJECTION22
68001-522-86FULVESTRANT5 mL in 1 SYRINGE, GLASSINJECTION52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-522-85ML - Milliliter68001-5229bb86642-4dbc-406a-81d0-f3f408b2174712021-12-08
68001-522-86ML - Milliliter68001-522f0d323a7-3532-469b-bce0-70c62702ee0112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-522FULVESTRANT INJECTION [BLUEPOINT LABORATORIES]2Current NDC, Legacy NDC, 2 package rows20220727_477098a1-cd37-48ad-b17f-aef610cb0f57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN477098a1-cd37-48ad-b17f-aef610cb0f572
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD477098a1-cd37-48ad-b17f-aef610cb0f572
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY477098a1-cd37-48ad-b17f-aef610cb0f572

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-522-85680010522852 SYRINGE, GLASS in 1 CARTON (68001-522-85) / 5 mL in 1 SYRINGE, GLASS (68001-522-86) 2021-10-290000-00-00NoNoCurrent
68001-522-86680010522865 mL in 1 SYRINGE, GLASS5 mlHistorical