FDA.reportPublic FDA data

Fulvestrant

Product NDC
0143-9022
11-digit product format
001439022
Labeler code
0143
Product ID
0143-9022_44dbf928-e93e-4f5e-8d1d-3b0e17f5d25f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fulvestrant
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA214682
Marketing category
ANDA
Marketing start
2022-02-10
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9022-01Fulvestrant5 mL in 1 SYRINGE, GLASSINJECTION54
0143-9022-02Fulvestrant2 in 1 CARTONINJECTION24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9022-01ML - Milliliter0143-902280f9c46d-0e04-45c9-99c4-273848a8d3a612022-08-04
0143-9022-02ML - Milliliter0143-9022b4e65e1c-e002-43fc-8f5d-dee03aaf6b3c12022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9022FULVESTRANT INJECTION [HIKMA PHARMACEUTICALS USA INC.]3Current NDC, Legacy NDC, 2 package rows20241122_306c283b-9abe-4985-856b-1957f1f3af8b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727762fulvestrant 250 MG in 5 ML Prefilled SyringePSN306c283b-9abe-4985-856b-1957f1f3af8b4
7277625 ML fulvestrant 50 MG/ML Prefilled SyringeSCD306c283b-9abe-4985-856b-1957f1f3af8b4
727762fulvestrant 250 MG per 5 ML Prefilled SyringeSY306c283b-9abe-4985-856b-1957f1f3af8b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9022-01001439022015 mL in 1 SYRINGE, GLASS5 mlHistorical
0143-9022-02001439022022 SYRINGE, GLASS in 1 CARTON (0143-9022-02) / 5 mL in 1 SYRINGE, GLASS (0143-9022-01) 2022-02-100000-00-00NoNoCurrent