Hydroxyprogesterone Caproate

Product NDC
69238-1797
11-digit product format
692381797
Labeler code
69238
Product ID
69238-1797_69e5d090-659a-48d7-870f-d6014743d263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydroxyprogesterone Caproate
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Amneal Pharmaceuticals of NY LLC
Application
ANDA210723
Marketing category
ANDA
Marketing start
2019-03-11
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3f8ce7d0-fe1e-f6af-e620-f015de6193caProduct name520200123
fc034902-c257-4d88-ae77-2436fbeafed3Product name220200121
2286aae4-2877-44f1-aa6e-273758ac39a3Product name220190628

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1797-1Hydroxyprogesterone Caproate1 in 1 BOXINJECTION113
69238-1797-1Hydroxyprogesterone Caproate1 mL in 1 VIALINJECTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1797-1ML - Milliliter69238-179734f763ab-fca0-4280-b067-ed315a5d600812019-04-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1797HYDROXYPROGESTERONE CAPROATE INJECTION [AMNEAL PHARMACEUTICALS OF NY LLC]13Legacy NDC, 2 package rows20220415_79cd136b-2098-43a4-aeec-7d8b8869f6ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1796690HYDROXYprogesterone caproate 250 MG in 1 ML InjectionPSN79cd136b-2098-43a4-aeec-7d8b8869f6ae13
17966901 ML hydroxyprogesterone caproate (USP) 250 MG/ML InjectionSCD79cd136b-2098-43a4-aeec-7d8b8869f6ae13
1796690hydroxyprogesterone caproate 250 MG per 1 ML InjectionSY79cd136b-2098-43a4-aeec-7d8b8869f6ae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1797-1692381797011 VIAL in 1 BOX (69238-1797-1) > 1 mL in 1 VIAL1 vial2019-03-110000-00-00NoNoCurrent