FDA.reportPublic FDA data

Chorionic Gonadotropin

Product NDC
63323-030
11-digit product format
633230030
Labeler code
63323
Product ID
63323-030_386cd061-6485-428c-aec1-a4f58d90d339
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chorionic Gonadotropin
Dosage form
KIT
Labeler
Fresenius Kabi USA, LLC
Application
BLA017067
Marketing category
BLA
Marketing start
2011-04-21
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chorionic Gonadotropin
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui896854

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
2f3e9b6e-e510-3ca6-ed62-ab4c1b132783Product name220200323
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63323-030-11Chorionic Gonadotropin1 in 1 CARTONKIT17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63323-030-11EA - Each63323-03078f6f741-98e5-41b8-a126-da59b42636c912016-12-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHORIOGONADOTROPIN ALFAACTIVE INGREDIENT6413W06WR3CHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
CHORIOGONADOTROPIN ALFAACTIVE MOIETY6413W06WR3CHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHCHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBCHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
MANNITOLINACTIVE INGREDIENT3OWL53L36ACHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ICHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74CHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWCHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCHORIONIC GONADOTROPIN (CHORIOGONADOTROPIN ALFA) KIT [APP PHARMACEUTICALS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63323-030CHORIONIC GONADOTROPIN KIT [FRESENIUS KABI USA, LLC]7Current NDC, Legacy NDC, 1 package rows20250419_f93b2baa-03ac-4650-b35a-20b818d712d6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896854chorionic gonadotropin 10,000 UNT/ML Injectable SolutionPSNf93b2baa-03ac-4650-b35a-20b818d712d67
896854chorionic gonadotropin 10000 UNT/ML Injectable SolutionSCDf93b2baa-03ac-4650-b35a-20b818d712d67
896854chorionic gonadotropin 10,000 UNT/ML Injectable SolutionPSN312ee87a-c6c3-6111-e063-6394a90ad8d71
896854chorionic gonadotropin 10000 UNT/ML Injectable SolutionSCD312ee87a-c6c3-6111-e063-6394a90ad8d71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63323-030-11633230030111 KIT in 1 CARTON (63323-030-11) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL, MULTI-DOSE1 kit2011-04-210000-00-00NoNoCurrent