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 Identifiers#

Field, Values table
FieldValues
Rxcui896854, 896856

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

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