NDC 50378-012-01 - Ovaprim

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
50378-012
Requested NDC
50378-012-01
Package NDCs from labels
50378-012-01, 50378-012-02
Manufacturer
Western Chemical Inc. | BCN Peptides SA
Effective date
2026-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ovaprim - Western Chemical Inc. | BCN Peptides SAWestern Chemical Inc. | BCN Peptides SA2026-05-21OTC ANIMAL DRUG LABEL
Ovaprim - Western Chemical Inc.Western Chemical Inc.2020-08-12OTC ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50378-012-01Ovaprim10 mL in 1 VIAL, GLASSINJECTION, SOLUTION108
50378-012-02Ovaprim1 in 1 CARTONINJECTION, SOLUTION18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50378-012OVAPRIM (SGNRHA AND DOMPERIDONE) INJECTION, SOLUTION [WESTERN CHEMICAL INC.]5Unmatched20200813_bed61e35-01c1-4171-87b9-2b66388673ad.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DomperidoneACTIVE INGREDIENT5587267Z69OVAPRIM (SGNRHA AND DOMPERIDONE) INJECTION, SOLUTION [WESTERN CHEMICAL INC.]3
SALMON GONADOTROPIN RELEASING HORMONE D-ARG6 ANALOG ETHYL AMIDE ACETATEACTIVE INGREDIENT66KW0E903IOVAPRIM (SGNRHA AND DOMPERIDONE) INJECTION, SOLUTION [WESTERN CHEMICAL INC.]3
DomperidoneACTIVE MOIETY5587267Z69OVAPRIM (SGNRHA AND DOMPERIDONE) INJECTION, SOLUTION [WESTERN CHEMICAL INC.]3
SALMON GONADOTROPIN RELEASING HORMONE D-ARG6 ANALOG ETHYL AMIDEACTIVE MOIETYWHI058YG4QOVAPRIM (SGNRHA AND DOMPERIDONE) INJECTION, SOLUTION [WESTERN CHEMICAL INC.]3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.