FDA.reportPublic FDA data

Alprostadil

Product NDC
71288-206
11-digit product format
712880206
Labeler code
71288
Product ID
71288-206_7e1975e8-b348-400d-a3aa-9a3ac1cba3b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Alprostadil
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVASCULAR
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA075196
Marketing category
ANDA
Marketing start
2024-09-15
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALPROSTADIL500 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF5TD010360
Rxcui237212

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
71288-206-01Alprostadil1 mL in 1 VIAL, SINGLE-USEINJECTION, SOLUTION, CONCENTRATE11
71288-206-02Alprostadil10 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-206-01ML - Milliliter71288-206e2cc1488-1208-4e6f-9dd1-38e2813fcb5312025-01-14
71288-206-02ML - Milliliter71288-206b0387f75-19a6-434f-a81e-b64a47de88cf12025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-206ALPROSTADIL INJECTION, SOLUTION, CONCENTRATE [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240915_35d229e1-6947-435c-bf54-bfa09cca7e53.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
237212alprostadil 500 MCG in 1 ML InjectionPSN35d229e1-6947-435c-bf54-bfa09cca7e531
2372121 ML alprostadil 0.5 MG/ML InjectionSCD35d229e1-6947-435c-bf54-bfa09cca7e531
237212alprostadil 500 MCG per 1 ML InjectionSY35d229e1-6947-435c-bf54-bfa09cca7e531

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71288-206-01712880206011 mL in 1 VIAL, SINGLE-USE1 mlHistorical
71288-206-027128802060210 VIAL, SINGLE-USE in 1 CARTON (71288-206-02) / 1 mL in 1 VIAL, SINGLE-USE (71288-206-01) 2024-09-15NoNoHistorical