PROSTIN
- Product NDC
- 0009-3169
- 11-digit product format
- 000093169
- Labeler code
- 0009
- Product ID
- 0009-3169_782de6bf-1523-48cc-b083-74b1b3940b81
- 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
- 1981-10-16
- 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| Ingredient | Strength |
|---|
| ALPROSTADIL | 500 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5TD010360 |
| Rxcui | 105467, 237212 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0009-3169-01 | PROSTINVR PEDIATRIC | 1 mL in 1 AMPULE | INJECTION, SOLUTION | 1 | | 11 |
| 0009-3169-06 | PROSTINVR PEDIATRIC | 5 in 1 PACKAGE | INJECTION, SOLUTION | 5 | | 11 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0009-3169 | PROSTIN VR PEDIATRIC (ALPROSTADIL) INJECTION, SOLUTION [PHARMACIA AND UPJOHN COMPANY LLC] | 9 | Current NDC, Legacy NDC, 2 package rows | 20200512_dea460fa-d05e-4191-8461-f185a711ad89.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0009-3169-01 | 00009316901 | 1 mL in 1 AMPULE | 1 ml | | | | | Historical |
| 0009-3169-06 | 00009316906 | 5 AMPULE in 1 PACKAGE (0009-3169-06) / 1 mL in 1 AMPULE (0009-3169-01) | 5 ampule | 1981-10-16 | 0000-00-00 | No | No | Current |