FDA.reportPublic FDA data

Fulvestrant

Product NDC
43598-262
11-digit product format
435980262
Labeler code
43598
Product ID
43598-262_67af235f-7f8b-da5b-5eb6-91d0b20b2a9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Dr.Reddy's Laboratories Inc
Application
ANDA209246
Marketing category
ANDA
Marketing start
2023-12-31
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
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
43598-262-02Fulvestrant2 in 1 CARTONINJECTION, SOLUTION219
43598-262-11Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION519
43598-262-23Fulvestrant2 in 1 CARTONINJECTION, SOLUTION219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-262-02ML - Milliliter43598-262ffea5f6c-7731-4740-a3f9-edad8d056f4912020-09-14
43598-262-11ML - Milliliter43598-26203ff9a88-c9c3-4495-be64-9a6c0bc8384112020-09-14
43598-262-23ML - Milliliter43598-262a0670a5a-4694-44ec-9686-8ad95414921712024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-262FULVESTRANT INJECTION, SOLUTION [DR.REDDY'S LABORATORIES INC]19Current NDC, Legacy NDC, 3 package rows20240906_2fc17ba3-83c7-a2b4-8a75-6a0cb1e07682.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN2fc17ba3-83c7-a2b4-8a75-6a0cb1e0768219
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD2fc17ba3-83c7-a2b4-8a75-6a0cb1e0768219
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY2fc17ba3-83c7-a2b4-8a75-6a0cb1e0768219

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-262-02435980262022 SYRINGE, GLASS in 1 CARTON (43598-262-02) / 5 mL in 1 SYRINGE, GLASS (43598-262-11) 2023-12-312026-05-31NoNoCurrent
43598-262-11435980262115 mL in 1 SYRINGE, GLASS5 mlHistorical
43598-262-23435980262232 SYRINGE, GLASS in 1 CARTON (43598-262-23) / 5 mL in 1 SYRINGE, GLASS (43598-262-11) 2024-09-05NoNoHistorical