FDA.reportPublic FDA data

Prepidil

Product NDC
0009-3359
11-digit product format
000093359
Labeler code
0009
Product ID
0009-3359_e72f678f-ff11-47d7-94ea-186113ec3fbd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
dinoprostone
Dosage form
GEL
Route
VAGINAL
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA019617
Marketing category
NDA
Marketing start
1992-12-09
Substance
DINOPROSTONE
Active strength
.5 mg/3g
Pharmacologic classes
Prostaglandin Analog [EPC], Prostaglandins [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Prepidil
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DINOPROSTONE.5 mg/3g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiK7Q1JQR04M
Rxcui208397, 309922

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ec05fe7c-3d4a-04dc-e557-6592b22322f9Product name120150831
66f853e1-4ba2-ac23-4f5d-e914cffa20b6Product name120150828

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-3359-01GM - Gram0009-335952a44bc9-d5b3-43d7-bf67-ede843f8005712013-12-02
0009-3359-02GM - Gram0009-3359159b59c4-40fa-4099-b21c-a00f5519e56c12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DINOPROSTONEACTIVE INGREDIENTK7Q1JQR04MPREPIDIL (DINOPROSTONE) GEL [PHARMACIA AND UPJOHN COMPANY]12
DINOPROSTONEACTIVE MOIETYK7Q1JQR04MPREPIDIL (DINOPROSTONE) GEL [PHARMACIA AND UPJOHN COMPANY]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PREPIDIL (DINOPROSTONE) GEL [PHARMACIA AND UPJOHN COMPANY]12
TRIACETININACTIVE INGREDIENTXHX3C3X673PREPIDIL (DINOPROSTONE) GEL [PHARMACIA AND UPJOHN COMPANY]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-3359PREPIDIL (DINOPROSTONE) GEL [PHARMACIA & UPJOHN COMPANY LLC]22Current NDC, Legacy NDC20250406_ab03de5b-782c-4f81-a8dc-7ef9969dd0cf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309922dinoprostone 0.5 MG in 3 GM Vaginal GelPSNab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
208397Prepidil 0.5 MG per 3 GM Vaginal GelPSNab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
208397dinoprostone 0.000167 MG/MG Vaginal Gel [Prepidil]SBDab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
309922dinoprostone 0.000167 MG/MG Vaginal GelSCDab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
309922dinoprostone 0.5 MG per 3 GM Vaginal GelSYab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
309922PGE2 0.000167 MG/MG Vaginal GelSYab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
208397PGE2 0.000167 MG/MG Vaginal Gel [Prepidil]SYab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
208397Prepidil 0.000167 MG/MG Vaginal GelSYab03de5b-782c-4f81-a8dc-7ef9969dd0cf23
208397Prepidil 0.5 MG per 3 GM Vaginal GelSYab03de5b-782c-4f81-a8dc-7ef9969dd0cf23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-3359-01000093359011 SYRINGE in 1 CARTON (0009-3359-01) / 3 g in 1 SYRINGE1 syringe2019-12-110000-00-00NoNoCurrent