Edex
- Product NDC
- 52244-020
- 11-digit product format
- 522440020
- Labeler code
- 52244
- Product ID
- 52244-020_66cf008c-1361-4fd1-8e5c-3e95981f8a76
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- alprostadil
- Dosage form
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
- Route
- INTRACAVERNOUS
- Labeler
- Endo USA, Inc.
- Application
- NDA020649
- Marketing category
- NDA
- Marketing start
- 2012-01-15
- Substance
- ALPROSTADIL
- Active strength
- 20 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
- Edex
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALPROSTADIL | 20 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | F5TD010360 |
| Rxcui | 1234236, 1234238, 1234239, 1234240, 1234241, 1234242 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52244-020-01 | Edex | 1 mL in 1 CARTRIDGE | INJECTION, POWDER, LYOPHILIZED, | 1 | | 16 |
| 52244-020-02 | Edex | 2 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 2 | | 16 |
| 52244-020-02 | Edex | 1 in 1 BLISTER PACK | INJECTION, POWDER, LYOPHILIZED, | 1 | | 16 |
| 52244-020-06 | Edex | 6 in 1 CARTON | INJECTION, POWDER, LYOPHILIZED, | 6 | | 16 |
| 52244-020-06 | Edex | 1 in 1 BLISTER PACK | INJECTION, POWDER, LYOPHILIZED, | 1 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| ALPROSTADIL | ACTIVE INGREDIENT | F5TD010360 | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC] | 2 | |
| ALPROSTADIL | ACTIVE MOIETY | F5TD010360 | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC] | 2 | |
| ALFADEX | INACTIVE INGREDIENT | Z1LH97KTRM | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC] | 2 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC] | 2 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC] | 2 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ACTIENT PHARMACEUTICALS, LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52244-020 | EDEX (ALPROSTADIL) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [ENDO USA, INC.] | 14 | Current NDC, Legacy NDC, 5 package rows | 20240425_e8b8ec8d-1318-43e4-a182-446e9f9579de.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 |
|---|
| 52244-020-01 | 52244002001 | 1 mL in 1 CARTRIDGE | 1 ml | | | | | Historical |
| 52244-020-02 | 52244002002 | 2 BLISTER PACK in 1 CARTON (52244-020-02) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-020-01) | 2 blister pack | 2012-01-15 | 0000-00-00 | No | No | Current |
| 52244-020-06 | 52244002006 | 6 BLISTER PACK in 1 CARTON (52244-020-06) / 1 CARTRIDGE in 1 BLISTER PACK / 1 mL in 1 CARTRIDGE (52244-020-01) | 6 blister pack | 2012-01-15 | 0000-00-00 | No | No | Current |