FDA.reportPublic FDA data

Pregnyl

Product NDC
0052-0315
11-digit product format
000520315
Labeler code
0052
Product ID
0052-0315_4107110b-c906-4a77-b6f2-e6b66c246f0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHORIOGONADOTROPIN ALFA
Dosage form
KIT
Labeler
Merck Sharp & Dohme LLC
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0052-0315DDiscontinued by firm2026-08-03
excluded packagepackage0052-03150052-0315-10DDiscontinued 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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0052-0315-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0052-0315-10f5e01cc5f278…a2eaf40c39c3…

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0052-0315-10EA - Each0052-0315e410eb10-1362-441b-976f-377cb8b5c24712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHORIOGONADOTROPIN ALFAACTIVE INGREDIENT6413W06WR3PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
CHORIOGONADOTROPIN ALFAACTIVE MOIETY6413W06WR3PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
WATERINACTIVE INGREDIENT059QF0KO0RPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [ORGANON USA INC.]10
CHORIOGONADOTROPIN ALFAACTIVE INGREDIENT6413W06WR3PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
CHORIOGONADOTROPIN ALFAACTIVE MOIETY6413W06WR3PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, DIBASICINACTIVE INGREDIENTGR686LBA74PREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SWPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RPREGNYL (CHORIOGONADOTROPIN ALFA) KIT [PHYSICIANS TOTAL CARE, INC.]1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
896854chorionic gonadotropin 10,000 UNT/ML Injectable SolutionPSNdc604794-6dd6-43a7-85fa-2f04ed325c331
896856Pregnyl 10,000 UNT/ML Injectable SolutionPSNdc604794-6dd6-43a7-85fa-2f04ed325c331
896856chorionic gonadotropin 10000 UNT/ML Injectable Solution [Pregnyl]SBDdc604794-6dd6-43a7-85fa-2f04ed325c331
896854chorionic gonadotropin 10000 UNT/ML Injectable SolutionSCDdc604794-6dd6-43a7-85fa-2f04ed325c331
896856Pregnyl 10,000 UNT/ML Injectable SolutionSYdc604794-6dd6-43a7-85fa-2f04ed325c331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0052-0315-10000520315101 KIT in 1 CARTON (0052-0315-10) * 10 mL in 1 VIAL, MULTI-DOSE * 10 mL in 1 VIAL1 kit1976-10-200000-00-00NoNoCurrent