HYDROXYPROGESTERONE CAPROATE

Product NDC
47335-037
11-digit product format
473350037
Labeler code
47335
Product ID
47335-037_dd6cda1c-d74f-4cc0-8027-bc2af7c1b1f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
HYDROXYPROGESTERONE CAPROATE
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA208381
Marketing category
ANDA
Marketing start
2019-07-01
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
2020-12-31
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47335-037-40HYDROXYPROGESTERONE CAPROATE1 in 1 CARTONINJECTION13
47335-037-40HYDROXYPROGESTERONE CAPROATE5 mL in 1 VIAL, MULTI-DOSEINJECTION53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47335-037HYDROXYPROGESTERONE CAPROATE INJECTION [SUN PHARMACEUTICAL INDUSTRIES, INC.]3Legacy NDC, 2 package rows20190701_458ed273-ef9c-4351-8bc2-173c3059d107.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087964HYDROXYprogesterone caproate 250 MG/ML Injectable SolutionPSN458ed273-ef9c-4351-8bc2-173c3059d1073
1087964hydroxyprogesterone caproate (USP) 250 MG/ML Injectable SolutionSCD458ed273-ef9c-4351-8bc2-173c3059d1073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
47335-037-40473350037401 VIAL, MULTI-DOSE in 1 CARTON (47335-037-40) > 5 mL in 1 VIAL, MULTI-DOSE2019-07-010000-00-00NoNoCurrent