FDA.reportPublic FDA data

Clomiphene Citrate

Product NDC
64980-690
11-digit product format
649800690
Labeler code
64980
Product ID
64980-690_621c3a1f-d194-4381-bde0-1574f108ac4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrtae
Dosage form
TABLET
Route
ORAL
Labeler
RISING PHARMA HOLDINGS, INC.
Application
ANDA216739
Marketing category
ANDA
Marketing start
2024-11-19
Substance
CLOMIPHENE CITRATE
Active strength
50 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], 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
Clomiphene Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPHENE CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1B8447E7YI
Rxcui1093060

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c924cb97-cd84-d0fe-8911-51a8a0fb2420Product name220250625

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64980-690-01Clomiphene Citrate10 in 1 BOTTLETABLET102
64980-690-03Clomiphene Citrate30 in 1 BOTTLETABLET302
64980-690-90Clomiphene Citrate1 in 1 CARTONTABLET12
64980-690-90Clomiphene Citrate10 in 1 BLISTER PACKTABLET102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64980-690-01EA - Each64980-69016ea6516-d3e9-4365-82f2-ce6cd519acea12025-10-14
64980-690-03EA - Each64980-690cce9abf2-3f9d-4679-8857-6d9699fc53fb12024-12-10
64980-690-90EA - Each64980-69088fa7406-6988-4b8a-a7ea-c322f160619312025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64980-690CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20241120_086eace1-51db-4d48-976c-9d39ef5be745.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093060clomiPHENE citrate 50 MG Oral TabletPSN086eace1-51db-4d48-976c-9d39ef5be7452
1093060clomiphene citrate 50 MG Oral TabletSCD086eace1-51db-4d48-976c-9d39ef5be7452

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
64980-690-016498006900110 TABLET in 1 BOTTLE (64980-690-01) 10 tablet2025-09-15NoNoCurrent
64980-690-036498006900330 TABLET in 1 BOTTLE (64980-690-03) 30 tablet2024-11-19NoNoCurrent
64980-690-90649800690901 BLISTER PACK in 1 CARTON (64980-690-90) / 10 TABLET in 1 BLISTER PACK1 blister pack2025-09-15NoNoCurrent