FDA.reportPublic FDA data

NDC 55566-1502-01 - Novarel

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
55566-1502
Requested NDC
55566-1502-01
Package NDCs from labels
55566-1502-1, 55566-1502-01
Manufacturer
Ferring Pharmaceuticals Inc.
Effective date
2025-08-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Novarel - Ferring Pharmaceuticals Inc.Ferring Pharmaceuticals Inc.2025-08-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

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

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 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

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 5 of 11 · 213 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
NovarelGONADOTROPHIN, CHORIONICFerring Pharmaceuticals Inc.ac6918ff-9dc3-40d9-8619-54b26e4bdfc82025-08-27Warnings, Adverse reactionsExact identifier
application number: BLA017016
ndc (package): 55566-1502-1
ndc (package): 55566-1700-0
ndc (product): 55566-1502
ndc11 (package): 55566150201
rxcui: 1865295
rxcui: 310587
spl id: dd63b1fd-1f0b-496b-b825-b1f8fb351dbb
spl set id: ac6918ff-9dc3-40d9-8619-54b26e4bdfc8
OsmitrolMANNITOLBaxter Healthcare Company0d914965-7001-45cb-ba51-d7c5964b05bc2025-08-26Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.d820e42d-ad2b-4e11-907b-a94d698ca2852025-08-13Warnings, Adverse reactionsExact identifier
unii: 3980JIH2SW
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Rexall Ready to use 4pk LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp, LLC78509915-0ef1-4238-99a5-78a49a68f98f2025-07-07WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
InterSolPLATELET ADDITIVE 3Fenwal, Inc.17dec820-1b57-4ac9-82a8-419cab664a2f2025-06-27Warnings, Adverse reactionsExact identifier
unii: GR686LBA74
Plaque identifyingPLAQUE IDENTIFYINGShenzhen Yagao Technology Co., Ltd.37eeb656-22f1-7372-e063-6394a90ad0412025-06-19WarningsExact identifier
unii: 059QF0KO0R
Saline LaxativeSODIUM PHOSPHATEWalgreen Companyfb260df0-7bda-4299-84a5-44c8f94477982025-06-18WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
PRISMASOL BGK2/0MAGNESIUM CHLORIDE, DEXTROSE ANHYDROUS, LACTIC ACID, SODIUM CHLORIDE, SODIUM BICARBONATE, AND POTASSIUM CHLORIDEVantive US Healthcare LLC7f675fee-8940-4ece-bb0c-75ac79d8708c2025-05-31Warnings, Adverse reactionsExact identifier
unii: GR686LBA74
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MannitolMANNITOLHenry Schein, Inc.e2444db1-9dfe-451f-a33c-9b00786464d22025-05-20Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Saline EnemaSODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASICDynarex Corporation7c7b68af-4ef2-4f84-9279-9f7a91c8d9c52025-05-14WarningsExact identifier
unii: GR686LBA74
unii: 3980JIH2SW
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
Bestmade Natural Products Field of Flowers FormulaAESCULUS CAR, AESCULUS HIP, AGRIMONIA EUP, BROMUS RAM, CALLUNA VULG, CARPINUS BET, CASTANEA SAT, CENTAURIUM UMB, CERATOSTIGMA WILLM, CICHORIUM INT, CLEMATIS VIT, FAGUS SYLV, GENTIANELLA AMARELLA, HELIANTHEMUM NUMMULARIUM, ILEX AQUIFOLIUM, IMPATIENS GLAND, LARIX DECIDUA, LONICERA CAPRIFOLIUM, MALUS, MIMULUS GUT, OLEA EUROP, ORNITHOGALUM UMB, PINUS SYL, POPULUS TREM, PRUNUS CERA, QUERCUS ROB, ROCK WATER, ROSA CAN, SALIX VIT, SCLERANTHUS ANNNUS, SINAPIS ARV, ULEX EURO, ULMUS PROC, VERBENA, VITIS VINBestmade Natural Products2fbf9b7c-e54f-589d-e063-6394a90a14a72025-03-07WarningsExact identifier
unii: 059QF0KO0R
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.