Clomiphene Citrate

Product NDC
16729-723
11-digit product format
167290723
Labeler code
16729
Product ID
16729-723_44e70204-6bed-9d96-e063-6294a90aa3cd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA219406
Marketing category
ANDA
Marketing start
2025-11-21
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

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
16729-723-44Clomiphene Citrate10 in 1 BLISTER PACKTABLET103
16729-723-44Clomiphene Citrate1 in 1 CARTONTABLET13
16729-723-51Clomiphene Citrate1 in 1 CARTONTABLET13
16729-723-51Clomiphene Citrate30 in 1 BLISTER PACKTABLET303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-723-44EA - Each16729-7238fd7c25b-75a0-4a25-a263-5f6f448b280712025-12-16
16729-723-51EA - Each16729-723358dec2f-5b10-4083-9f49-1fa6f3c41ae412025-12-16

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093060clomiPHENE citrate 50 MG Oral TabletPSN79f64995-7425-44c6-9f44-f7d20daeff653
1093060clomiphene citrate 50 MG Oral TabletSCD79f64995-7425-44c6-9f44-f7d20daeff653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16729-723-441672907234410 in 1 BLISTER PACKHistorical
16729-723-51167290723511 BLISTER PACK in 1 CARTON (16729-723-51) / 30 TABLET in 1 BLISTER PACK1 blister pack2025-11-21NoNoCurrent