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These highlights do not include all the information needed to use HYDROXYPROGESTERONE CAPROATE INJECTION safely and effectively. See full prescribing information for HYDROXYPROGESTERONE CAPROATE INJECTION. HYDROXYPROGESTERONE CAPROATE injection, for intramuscular use. Initial U.S. Approval: 1956
Medication labelWhy this: Advisory · dailymed-prescription
Hydroxyprogesterone caproate injection is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of hydroxyprogesterone caproate injection is based on improvement in the proportion of women who delivered < 37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity. Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of hydroxyprogesterone caproate injection has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
- generic_name
- hydroxyprogesterone caproate
- product_names
- Hydroxyprogesterone Caproate
- ndc
- 69238-1797, 69238-1797-1
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en