FDA.reportPublic FDA data

Ovidrel

Product NDC
44087-1150
11-digit product format
440871150
Labeler code
44087
Product ID
44087-1150_59d39f88-54fb-480a-979b-4d3d2c7c2cd4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
choriogonadotropin alfa
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
EMD Serono, Inc.
Application
BLA021149
Marketing category
BLA
Marketing start
2003-10-06
Substance
CHORIOGONADOTROPIN ALFA
Active strength
250 ug/.5mL
Pharmacologic classes
Gonadotropin [EPC], Gonadotropins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHORIOGONADOTROPIN ALFA250 ug/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6413W06WR3Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
727505Internal RxNorm lookup
727507Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a683e58a-63ea-44b8-a326-1a99a537bcf2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f3e9b6e-e510-3ca6-ed62-ab4c1b132783Product name220200323
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44087-1150-12022-02-02C16284748780-1d6a99b39-dc00-a426-e053-dadaa90af4c2OVIDREL ® PreFilled Syringe (choriogonadotropin alfa injection)
44087-1150-12022-01-28C16284748780-1d6a99b39-dc00-a426-e053-dadaa90af4c2OVIDREL ® PreFilled Syringe (choriogonadotropin alfa injection)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44087-1150-1Ovidrel0.5 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION0.510
44087-1150-1Ovidrel1 in 1 CARTONINJECTION, SOLUTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44087-1150-1ML - Milliliter44087-115089fce669-a8ad-47d8-b49c-7ac5c266eb7612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHORIOGONADOTROPIN ALFAACTIVE INGREDIENT6413W06WR3OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
CHORIOGONADOTROPIN ALFAACTIVE MOIETY6413W06WR3OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
MANNITOLINACTIVE INGREDIENT3OWL53L36AOVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
METHIONINEINACTIVE INGREDIENTAE28F7PNPLOVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNOVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IOVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0ROVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44087-1150OVIDREL (CHORIOGONADOTROPIN ALFA) INJECTION, SOLUTION [EMD SERONO, INC.]10Current NDC, Legacy NDC, 2 package rows20231228_a683e58a-63ea-44b8-a326-1a99a537bcf2.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OvidrelCHORIOGONADOTROPIN ALFAEMD Serono, Inc.a683e58a-63ea-44b8-a326-1a99a537bcf22023-12-26Warnings, Adverse reactionsExact identifier
application number: BLA021149
ndc (product): 44087-1150

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
021149Ovidrelchoriogonadotropin alfa351(a)Disc2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727505choriogonadotropin alfa 250 MCG in 0.5 ML Prefilled SyringePSNa683e58a-63ea-44b8-a326-1a99a537bcf210
727507Ovidrel 250 MCG in 0.5 mL Prefilled SyringePSNa683e58a-63ea-44b8-a326-1a99a537bcf210
7275070.5 ML choriogonadotropin alfa 0.5 MG/ML Prefilled Syringe [Ovidrel]SBDa683e58a-63ea-44b8-a326-1a99a537bcf210
7275050.5 ML choriogonadotropin alfa 0.5 MG/ML Prefilled SyringeSCDa683e58a-63ea-44b8-a326-1a99a537bcf210
7275070.5 ML Ovidrel 0.5 MG/ML Prefilled SyringeSYa683e58a-63ea-44b8-a326-1a99a537bcf210
727505choriogonadotropin alfa 0.25 MG per 0.5 ML Prefilled SyringeSYa683e58a-63ea-44b8-a326-1a99a537bcf210
727505choriogonadotropin alfa 250 MCG per 0.5 ML Prefilled SyringeSYa683e58a-63ea-44b8-a326-1a99a537bcf210
727507Ovidrel 250 MCG per 0.5 ML Prefilled SyringeSYa683e58a-63ea-44b8-a326-1a99a537bcf210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
44087-1150-1440871150011 SYRINGE, GLASS in 1 CARTON (44087-1150-1) / .5 mL in 1 SYRINGE, GLASS2003-10-060000-00-00NoNoCurrent