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 Identifiers#

Field, Values table
FieldValues
Rxcui896854, 896856

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

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 kit2023-06-02NoNoHistorical
78206-150-997820601509910 mL in 1 VIAL, MULTI-DOSE10 mlHistorical