FDA.reportPublic FDA data

Pregnyl

Product NDC
78206-150
11-digit product format
782060150
Labeler code
78206
Product ID
78206-150_11f90621-6a2d-4c75-9f32-3e6180df7618
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHORIOGONADOTROPIN ALFA
Dosage form
KIT
Labeler
Organon LLC
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
1e94155f-19be-4944-b197-be4edbb4faf9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2f3e9b6e-e510-3ca6-ed62-ab4c1b132783Product name220200323
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78206-150-01Pregnyl1 in 1 CARTONKIT111
78206-150-99Pregnyl10 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,10 mL10000 [USP'U] in 10mL11
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
78206-150-01EA - Each78206-150494b84d3-694c-419e-84fd-5ff810206cbd12023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78206-150PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON LLC]10Current NDC, 2 package rows20250515_1e94155f-19be-4944-b197-be4edbb4faf9.zip
78206-150PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [A-S MEDICATION SOLUTIONS]2Current NDC20240229_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
ndc (product): 78206-150
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896854chorionic gonadotropin 10,000 UNT/ML Injectable SolutionPSN1e94155f-19be-4944-b197-be4edbb4faf911
896856Pregnyl 10,000 UNT/ML Injectable SolutionPSN1e94155f-19be-4944-b197-be4edbb4faf911
896856chorionic gonadotropin 10000 UNT/ML Injectable Solution [Pregnyl]SBD1e94155f-19be-4944-b197-be4edbb4faf911
896854chorionic gonadotropin 10000 UNT/ML Injectable SolutionSCD1e94155f-19be-4944-b197-be4edbb4faf911
896856Pregnyl 10,000 UNT/ML Injectable SolutionSY1e94155f-19be-4944-b197-be4edbb4faf911
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
78206-150-01782060150011 KIT in 1 CARTON (78206-150-01) * 10 mL in 1 VIAL, MULTI-DOSE (78206-150-99) * 10 mL in 1 VIAL (78206-151-89) 1 kit2023-06-02NoNoCurrent
78206-150-997820601509910 mL in 1 VIAL, MULTI-DOSE10 mlHistorical