FDA.reportPublic FDA data

Fulvestrant

Product NDC
70860-211
11-digit product format
708600211
Labeler code
70860
Product ID
70860-211_2cc985f3-36aa-f803-e063-6394a90a06f1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fulvestrant
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Athenex Pharmaceutical Division, LLC.
Application
ANDA211422
Marketing category
ANDA
Marketing start
2020-02-18
Marketing end
2026-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70860-211-742024-03-03C16284748780-11030e365-5cae-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FULVESTRANT INJECTION safely and effectively. See full prescribing information for FULVESTRANT INJECTION. FULVESTRANT injection, for intramuscular use Initial U.S. Approval: 2002
70860-211-742024-01-30C16284748780-11030e365-5cae-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use FULVESTRANT INJECTION safely and effectively. See full prescribing information for FULVESTRANT INJECTION. FULVESTRANT injection, for intramuscular use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70860-211-41Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION56
70860-211-74Fulvestrant2 in 1 CARTONINJECTION, SOLUTION26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70860-211-41ML - Milliliter70860-21156965d98-f373-4622-9c06-4c8decc2290e12020-03-10
70860-211-74ML - Milliliter70860-21134ae8466-8b87-46ae-a770-bccc1a582cf112020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70860-211FULVESTRANT INJECTION, SOLUTION [ATHENEX PHARMACEUTICAL DIVISION, LLC.]6Current NDC, Legacy NDC, 2 package rows20250130_8ed06e0e-c17b-4c71-8d03-888bcde4a638.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN8ed06e0e-c17b-4c71-8d03-888bcde4a6386
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD8ed06e0e-c17b-4c71-8d03-888bcde4a6386
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY8ed06e0e-c17b-4c71-8d03-888bcde4a6386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70860-211-41708600211415 mL in 1 SYRINGE, GLASS5 mlHistorical
70860-211-74708600211742 SYRINGE, GLASS in 1 CARTON (70860-211-74) / 5 mL in 1 SYRINGE, GLASS (70860-211-41) 2020-02-182026-12-31NoNoCurrent