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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896854Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f93b2baa-03ac-4650-b35a-20b818d712d6Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chorionic GonadotropinCHORIONIC GONADOTROPINFresenius Kabi USA, LLCf93b2baa-03ac-4650-b35a-20b818d712d62025-04-11Warnings, Adverse reactionsExact identifier
application number: BLA017067
ndc (product): 63323-030
Chorionic GonadotropinCHORIONIC GONADOTROPINNuCare Pharmaceuticals,Inc.312ee87a-c6c3-6111-e063-6394a90ad8d72025-03-25Warnings, Adverse reactionsExact identifier
application number: BLA017067

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017067Chorionic Gonadotropinchorionic gonadotropin351(a)Disc2026-06-01

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