FDA.reportPublic FDA data

Novarel

Product NDC
55566-1502
11-digit product format
555661502
Labeler code
55566
Product ID
55566-1502_dd63b1fd-1f0b-496b-b825-b1f8fb351dbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
gonadotrophin, chorionic
Dosage form
KIT
Labeler
Ferring Pharmaceuticals Inc.
Application
BLA017016
Marketing category
BLA
Marketing start
2017-08-30
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui310587, 1865295

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55566-1502-1Novarel1 in 1 CARTONKIT141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55566-1502-1EA - Each55566-15026decc59c-b32d-4663-8aa7-3016f24a0c4712017-10-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Gonadotrophin, ChorionicACTIVE INGREDIENT20ED16GHEBNOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]20
Gonadotrophin, ChorionicACTIVE MOIETY20ED16GHEBNOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]20
MannitolINACTIVE INGREDIENT3OWL53L36ANOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]20
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]20
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWNOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]20
WaterINACTIVE INGREDIENT059QF0KO0RNOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55566-1502NOVAREL (GONADOTROPHIN, CHORIONIC) KIT [FERRING PHARMACEUTICALS INC.]39Current NDC, Legacy NDC, 1 package rows20241122_ac6918ff-9dc3-40d9-8619-54b26e4bdfc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310587chorionic gonadotropin 5000 UNT/ML Injectable SolutionPSNac6918ff-9dc3-40d9-8619-54b26e4bdfc841
1865295Novarel 5000 UNT/ML Injectable SolutionPSNac6918ff-9dc3-40d9-8619-54b26e4bdfc841
1865295chorionic gonadotropin 5000 UNT/ML Injectable Solution [Novarel]SBDac6918ff-9dc3-40d9-8619-54b26e4bdfc841
310587chorionic gonadotropin 5000 UNT/ML Injectable SolutionSCDac6918ff-9dc3-40d9-8619-54b26e4bdfc841
1865295Novarel 5000 UNT/ML Injectable SolutionSYac6918ff-9dc3-40d9-8619-54b26e4bdfc841

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55566-1502-1555661502011 KIT in 1 CARTON (55566-1502-1) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL * 10 mL in 1 VIAL (55566-1700-0) 1 kit2017-08-300000-00-00NoNoCurrent