FDA.reportPublic FDA data

Fulvestrant

Product NDC
62332-650
11-digit product format
623320650
Labeler code
62332
Product ID
62332-650_8e24c62a-357f-4613-a936-d6e9088db32c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215077
Marketing category
ANDA
Marketing start
2022-12-22
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
62332-650-05Fulvestrant5 mL in 1 SYRINGEINJECTION510
62332-650-10Fulvestrant2 in 1 CARTONINJECTION210

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-650-05ML - Milliliter62332-6506595f632-c54b-45bb-8056-1079d51d562412023-09-05
62332-650-10ML - Milliliter62332-65053704133-a669-4f09-a84f-22380f9e50a812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-650FULVESTRANT INJECTION [ALEMBIC PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20241220_b02915fe-6c44-48c1-aaeb-997ddc59a595.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSNb02915fe-6c44-48c1-aaeb-997ddc59a59510
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCDb02915fe-6c44-48c1-aaeb-997ddc59a59510
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSYb02915fe-6c44-48c1-aaeb-997ddc59a59510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-650-05623320650052 SYRINGE in 1 CARTON (62332-650-05) > 5 mL in 1 SYRINGE (62332-650-11) 2 syringe2022-12-220000-00-00NoNoCurrent
62332-650-10623320650102 SYRINGE in 1 CARTON (62332-650-10) / 5 mL in 1 SYRINGE (62332-650-05) 2 syringe2022-12-22NoNoHistorical