FDA.reportPublic FDA data

Hydroxyprogesterone Caproate

Product NDC
0517-1767
Requested package NDC
0517-1767-01
11-digit product format
005171767
Labeler code
0517
Product ID
0517-1767_4207c2b1-a227-4a27-9768-557a02ec4791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyprogesterone Caproate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
American Regent, Inc.
Application
ANDA210723
Marketing category
ANDA
Marketing start
2018-06-28
Marketing end
0000-00-00
Substance
HYDROXYPROGESTERONE CAPROATE
Active strength
250 mg/mL
Pharmacologic classes
Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0517-17670517-1767-01DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-1767-01ML - Milliliter0517-1767855053e5-9a0a-484d-a4ee-68bb905897cc12018-07-03

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-1767-01005171767011 VIAL in 1 BOX (0517-1767-01) > 1 mL in 1 VIAL1 vial2018-06-280000-00-00NoNoCurrent