FDA.reportPublic FDA data

PROSTIN

Product NDC
0009-0215
11-digit product format
000090215
Labeler code
0009
Product ID
0009-0215_86df82a7-5bba-4292-b34c-032daa818e45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alprostadil
Dosage form
INJECTION, SOLUTION
Route
INTRAVASCULAR; INTRAVENOUS
Labeler
Pharmacia & Upjohn Company LLC
Application
NDA018484
Marketing category
NDA
Marketing start
2022-10-03
Substance
ALPROSTADIL
Active strength
500 ug/mL
Pharmacologic classes
Genitourinary Arterial Vasodilation [PE], Prostaglandin Analog [EPC], Prostaglandin E1 Agonist [EPC], Prostaglandin Receptor Agonists [MoA], Prostaglandins [CS], Venous Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PROSTIN
Brand name suffix
VR PEDIATRIC
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPROSTADIL500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5TD010360
Rxcui105467, 237212

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3c3468-d7dd-dbc7-68a7-e177b6ff0c9cProduct name120140508
9a159c5b-579d-e616-cae2-48cf73594159Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0009-0215-01PROSTINVR PEDIATRIC1 mL in 1 AMPULEINJECTION, SOLUTION13
0009-0215-05PROSTINVR PEDIATRIC5 in 1 PACKAGEINJECTION, SOLUTION53

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0009-0215-01ML - Milliliter0009-0215e8e9ad16-13d6-4c4b-ad99-fbc4ffabe4cc12022-11-07
0009-0215-05ML - Milliliter0009-02152cd165fa-8dfb-4f8e-9985-659ee09e27f212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0009-0215PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA & UPJOHN COMPANY LLC]1Current NDC, Legacy NDC, 2 package rows20221003_930f8c02-46a8-4cff-a484-660468ab23c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237212alprostadil 500 MCG in 1 ML InjectionPSN930f8c02-46a8-4cff-a484-660468ab23c33
105467Prostin VR Pediatric 500 MCG in 1 ML InjectionPSN930f8c02-46a8-4cff-a484-660468ab23c33
1054671 ML alprostadil 0.5 MG/ML Injection [Prostin VR]SBD930f8c02-46a8-4cff-a484-660468ab23c33
2372121 ML alprostadil 0.5 MG/ML InjectionSCD930f8c02-46a8-4cff-a484-660468ab23c33
1054671 ML Prostin VR 0.5 MG/ML InjectionSY930f8c02-46a8-4cff-a484-660468ab23c33
237212alprostadil 500 MCG per 1 ML InjectionSY930f8c02-46a8-4cff-a484-660468ab23c33
105467Prostin VR Pediatric 500 MCG per 1 ML InjectionSY930f8c02-46a8-4cff-a484-660468ab23c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0009-0215-01000090215011 mL in 1 AMPULE1 mlHistorical
0009-0215-05000090215055 AMPULE in 1 PACKAGE (0009-0215-05) / 1 mL in 1 AMPULE (0009-0215-01) 5 ampule2022-10-030000-00-00NoNoCurrent