Clomiphene Citrate

Product NDC
55801-187
11-digit product format
558010187
Labeler code
55801
Product ID
55801-187_b22cc371-c969-4446-8cba-32a7e469ae80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrtae
Dosage form
TABLET
Route
ORAL
Labeler
Appco Pharma LLC
Application
ANDA216739
Marketing category
ANDA
Marketing start
2024-11-18
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
55801-187-01Clomiphene Citrate30 in 1 BOTTLETABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55801-187CLOMIPHENE CITRATE (CLOMIPHENE CITRTAE) TABLET [APPCO PHARMA LLC]4Current NDC, 1 package rows20241201_2d257ec2-827c-4bc2-8f17-cf24520c3cad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093060clomiPHENE citrate 50 MG Oral TabletPSN2d257ec2-827c-4bc2-8f17-cf24520c3cad4
1093060clomiphene citrate 50 MG Oral TabletSCD2d257ec2-827c-4bc2-8f17-cf24520c3cad4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55801-187-015580101870130 TABLET in 1 BOTTLE (55801-187-01) 30 tablet2024-11-18NoNoHistorical