FDA.reportPublic FDA data

fulvestrant

Product NDC
25021-471
11-digit product format
250210471
Labeler code
25021
Product ID
25021-471_c42819d9-59df-44fa-aa7a-e510311dbbb8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
fulvestrant
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Sagent Pharmaceuticals
Application
ANDA211422
Marketing category
ANDA
Marketing start
2026-04-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
fulvestrant
Listing expiration
2027-12-31

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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
25021-471-66fulvestrant5 mL in 1 SYRINGEINJECTION, SOLUTION51
25021-471-66fulvestrant2 in 1 CARTONINJECTION, SOLUTION21
25021-471-74fulvestrant2 in 1 CARTONINJECTION, SOLUTION21
25021-471-74fulvestrant5 mL in 1 SYRINGEINJECTION, SOLUTION51

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-471-66ML - Milliliter25021-47131823414-6208-450e-ba18-dc8bd322c4a812026-05-22
25021-471-74ML - Milliliter25021-471e51c3195-6881-4a2c-8103-056d46df679412024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
25021-471FULVESTRANT INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]1Current NDC, 2 package rows20240915_0f05b699-c440-42c1-9557-46759a10ab17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN0f05b699-c440-42c1-9557-46759a10ab171
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSNd5ae9e07-73b0-4063-a9e4-0ffc5614c2b81
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD0f05b699-c440-42c1-9557-46759a10ab171
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCDd5ae9e07-73b0-4063-a9e4-0ffc5614c2b81
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY0f05b699-c440-42c1-9557-46759a10ab171
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSYd5ae9e07-73b0-4063-a9e4-0ffc5614c2b81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-471-66250210471662 SYRINGE in 1 CARTON (25021-471-66) / 5 mL in 1 SYRINGE2 syringe2026-04-15NoNoHistorical
25021-471-74250210471742 SYRINGE in 1 CARTON (25021-471-74) / 5 mL in 1 SYRINGE2 syringe2024-09-15NoNoHistorical