Clomiphene Citrate

Product NDC
83390-107
11-digit product format
833900107
Labeler code
83390
Product ID
83390-107_3ce28083-f9f3-c59f-e063-6394a90a92e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Cosette Pharmaceuticals NC Laboratories, LLC
Application
ANDA075528
Marketing category
ANDA
Marketing start
2025-08-21
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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
1B8447E7YICLOMIPHENE CITRATE50-41-9CLOMIPHENE CITRATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83390-107-09833900107091 BLISTER PACK in 1 CARTON (83390-107-09) / 10 TABLET in 1 BLISTER PACK1 blister pack2025-08-21NoNoHistorical
83390-107-30833900107303 BLISTER PACK in 1 CARTON (83390-107-30) / 10 TABLET in 1 BLISTER PACK3 blister pack2025-08-21NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
clomiPHENE Citrate Tablets, USP Rx OnlyCosette Pharmaceuticals NC Laboratories, LLC2025-08-21HUMAN PRESCRIPTION DRUG LABEL4