Clomiphene Citrate

Product NDC
72888-213
11-digit product format
728880213
Labeler code
72888
Product ID
72888-213_42c33e9f-eb66-30dd-e063-6294a90a16b1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA216545
Marketing category
ANDA
Marketing start
2024-11-12
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
72888-213-08Clomiphene Citrate1 in 1 CARTONTABLET13
72888-213-08Clomiphene Citrate10 in 1 BLISTER PACKTABLET103
72888-213-58Clomiphene Citrate3 in 1 CARTONTABLET33
72888-213-58Clomiphene Citrate10 in 1 BLISTER PACKTABLET103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-213-08EA - Each72888-21306e4a06e-d25a-4e5c-a15b-0d85b651e8a612025-10-14
72888-213-58EA - Each72888-213d67e4d49-975d-4094-8f35-3dfeb8cce8d712025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-213CLOMIPHENE CITRATE TABLET [ADVAGEN PHARMA LTD]1Current NDC, 4 package rows20241122_c7baae81-74ef-4e36-a454-15e9b0fea7e5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093060clomiPHENE citrate 50 MG Oral TabletPSNc7baae81-74ef-4e36-a454-15e9b0fea7e53
1093060clomiphene citrate 50 MG Oral TabletSCDc7baae81-74ef-4e36-a454-15e9b0fea7e53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72888-213-08728880213081 BLISTER PACK in 1 CARTON (72888-213-08) / 10 TABLET in 1 BLISTER PACK1 blister pack2024-11-12NoNoCurrent
72888-213-58728880213583 BLISTER PACK in 1 CARTON (72888-213-58) / 10 TABLET in 1 BLISTER PACK3 blister pack2024-11-12NoNoCurrent