FDA.reportPublic FDA data

Pregnyl

Product NDC
50090-5923
Requested package NDC
50090-5923-0
11-digit product format
500905923
Labeler code
50090
Product ID
50090-5923_0b3b1b5d-bb91-4ad9-bc9c-80f1d34db80f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHORIOGONADOTROPIN ALFA
Dosage form
KIT
Labeler
A-S Medication Solutions
Application
BLA017692
Marketing category
BLA
Marketing start
1976-10-20
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-592350090-5923-0DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-592350090-5923-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-592350090-5923-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5923-0EA - Each50090-59235e59c646-355f-4399-a270-936b3c5e1dde12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5923PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [A-S MEDICATION SOLUTIONS]2Legacy NDC20231207_6c9bc522-0999-4cdd-bdfe-c886a1cadd43.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

Purple Book Biologic Products#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5923-0500905923001 KIT in 1 KIT (50090-5923-0) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL1 kit2022-02-180000-00-00NoNoCurrent