FDA.reportPublic FDA data

Fulvestrant

Product NDC
70121-1463
11-digit product format
701211463
Labeler code
70121
Product ID
70121-1463_7ee9004c-c1b0-4410-aaa7-7f6a52dca896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA210044
Marketing category
ANDA
Marketing start
2025-06-03
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70121-1463-2Fulvestrant2 in 1 CARTONINJECTION, SOLUTION216
70121-1463-3Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION516
70121-1463-1Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION51
70121-1463-9Fulvestrant2 in 1 CARTONINJECTION, SOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70121-1463-1ML - Milliliter70121-14631d3dacce-07b6-4c6c-9a62-4469bdc62d8912026-01-08
70121-1463-2ML - Milliliter70121-1463814f36ab-b091-4c12-aa8b-c3fbd3128bfb12019-11-12
70121-1463-3ML - Milliliter70121-146399e792e3-a61b-4f9c-9fa6-bf6c4392e33612026-01-08
70121-1463-9ML - Milliliter70121-14636c553af7-13c5-4011-8235-bcc660052f1812026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70121-1463FULVESTRANT INJECTION, SOLUTION [AMNEAL PHARMACEUTICALS LLC]15Current NDC, Legacy NDC, 2 package rows20240928_f36f19ad-f044-4dba-80b6-d074ddffcd86.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSNf36f19ad-f044-4dba-80b6-d074ddffcd8616
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCDf36f19ad-f044-4dba-80b6-d074ddffcd8616
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSYf36f19ad-f044-4dba-80b6-d074ddffcd8616
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSNa51aa693-b433-4b2d-a71b-9ba029b10ce31
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCDa51aa693-b433-4b2d-a71b-9ba029b10ce31
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSYa51aa693-b433-4b2d-a71b-9ba029b10ce31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70121-1463-1701211463015 mL in 1 SYRINGE, GLASS5 mlHistorical
70121-1463-2701211463022 SYRINGE, GLASS in 1 CARTON (70121-1463-2) / 5 mL in 1 SYRINGE, GLASS (70121-1463-3) 2019-03-040000-00-00NoNoCurrent
70121-1463-3701211463035 mL in 1 SYRINGE, GLASS5 mlHistorical
70121-1463-9701211463092 SYRINGE, GLASS in 1 CARTON (70121-1463-9) / 5 mL in 1 SYRINGE, GLASS (70121-1463-1) 2025-06-03NoNoHistorical