FDA.reportPublic FDA data

PREGNYL

Product NDC
50090-7089
11-digit product format
500907089
Labeler code
50090
Product ID
50090-7089_58a04b61-cc76-4acc-b0a5-984d8b802c9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHORIOGONADOTROPIN ALFA
Dosage form
KIT
Labeler
A-S Medication Solutions
Application
BLA017692
Marketing category
BLA
Marketing start
2023-06-02
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
896854Internal RxNorm lookup
896856Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f803acfc-06ea-4841-be9e-10d49fa5caecAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2f3e9b6e-e510-3ca6-ed62-ab4c1b132783Product name220200323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7089-0PREGNYL1 in 1 KITKIT12
78206-150-99PREGNYL10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,10 mL10000 [USP'U] in 10mL2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7089-0EA - Each50090-708998788562-69f5-4412-bd3d-d7c80ed9c04a12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7089PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [A-S MEDICATION SOLUTIONS]2Current NDC, 2 package rows20240229_f803acfc-06ea-4841-be9e-10d49fa5caec.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
PregnylCHORIOGONADOTROPIN ALFAOrganon LLC1e94155f-19be-4944-b197-be4edbb4faf92025-12-02Warnings, Adverse reactionsExact identifier
application number: BLA017692
PREGNYLCHORIOGONADOTROPIN ALFAA-S Medication Solutionsf803acfc-06ea-4841-be9e-10d49fa5caec2024-02-18Warnings, Adverse reactionsExact identifier
application number: BLA017692
ndc (product): 50090-7089

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
017692Pregnylchorionic gonadotropin351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896854chorionic gonadotropin 10,000 UNT/ML Injectable SolutionPSNf803acfc-06ea-4841-be9e-10d49fa5caec2
896856Pregnyl 10,000 UNT/ML Injectable SolutionPSNf803acfc-06ea-4841-be9e-10d49fa5caec2
896856chorionic gonadotropin 10000 UNT/ML Injectable Solution [Pregnyl]SBDf803acfc-06ea-4841-be9e-10d49fa5caec2
896854chorionic gonadotropin 10000 UNT/ML Injectable SolutionSCDf803acfc-06ea-4841-be9e-10d49fa5caec2
896856Pregnyl 10,000 UNT/ML Injectable SolutionSYf803acfc-06ea-4841-be9e-10d49fa5caec2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7089-0500907089001 KIT in 1 KIT (50090-7089-0) * 10 mL in 1 VIAL, MULTI-DOSE (78206-150-99) * 10 mL in 1 VIAL (78206-151-89) 1 kit2024-02-12NoNoCurrent
78206-150-997820601509910 mL in 1 VIAL, MULTI-DOSE10 mlHistorical