Clomid

Product NDC
0713-0885
11-digit product format
007130885
Labeler code
0713
Product ID
0713-0885_2d02613b-bc31-bf2c-e063-6394a90a32cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomiphene Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Cosette Pharmaceuticals, Inc.
Application
ANDA075528
Marketing category
ANDA
Marketing start
2022-09-09
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
Clomid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPHENE CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii1B8447E7YI
Rxcui1093060, 1093073

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
0713-0885-09Clomid1 in 1 CARTONTABLET13
0713-0885-09Clomid10 in 1 BLISTER PACKTABLET103
0713-0885-30Clomid10 in 1 BLISTER PACKTABLET103
0713-0885-30Clomid3 in 1 CARTONTABLET33

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0885-09EA - Each0713-08857155f84f-039a-4a6e-9b29-a9785f72008012022-07-06
0713-0885-30EA - Each0713-0885730cc85b-82b9-43c5-8b57-2d2c94eaae9f12022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0713-0885CLOMID (CLOMIPHENE CITRATE) TABLET [COSETTE PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 4 package rows20250201_2ca373c1-4dba-4126-8616-5c533d606fe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093073Clomid 50 MG Oral TabletPSN2ca373c1-4dba-4126-8616-5c533d606fe53
1093060clomiPHENE citrate 50 MG Oral TabletPSN2ca373c1-4dba-4126-8616-5c533d606fe53
1093073clomiphene citrate 50 MG Oral Tablet [Clomid]SBD2ca373c1-4dba-4126-8616-5c533d606fe53
1093060clomiphene citrate 50 MG Oral TabletSCD2ca373c1-4dba-4126-8616-5c533d606fe53
1093073Clomid 50 MG Oral TabletSY2ca373c1-4dba-4126-8616-5c533d606fe53
1093073Clomid 50 MG Oral TabletPSNf15e9918-6001-4150-bd54-1364a6febcb81
1093060clomiPHENE citrate 50 MG Oral TabletPSNf15e9918-6001-4150-bd54-1364a6febcb81
1093073clomiphene citrate 50 MG Oral Tablet [Clomid]SBDf15e9918-6001-4150-bd54-1364a6febcb81
1093060clomiphene citrate 50 MG Oral TabletSCDf15e9918-6001-4150-bd54-1364a6febcb81
1093073Clomid 50 MG Oral TabletSYf15e9918-6001-4150-bd54-1364a6febcb81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0713-0885-09007130885091 BLISTER PACK in 1 CARTON (0713-0885-09) / 10 TABLET in 1 BLISTER PACK1 blister pack2022-09-120000-00-00NoNoCurrent
0713-0885-30007130885303 BLISTER PACK in 1 CARTON (0713-0885-30) / 10 TABLET in 1 BLISTER PACK3 blister pack2022-09-090000-00-00NoNoCurrent