AURLUMYN
- Product NDC
- 50633-340
- 11-digit product format
- 506330340
- Labeler code
- 50633
- Product ID
- 50633-340_445e0469-117b-0ed5-e063-6394a90abe40
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- ILOPROST
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BTG International Inc
- Application
- NDA217933
- Marketing category
- NDA
- Marketing start
- 2025-08-01
- Substance
- ILOPROST
- Active strength
- 100 ug/mL
- Pharmacologic classes
- Prostacycline [EPC], Prostaglandins I [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AURLUMYN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ILOPROST | 100 ug/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | JED5K35YGL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50633-340-01 | AURLUMYN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 50633-340-01 | AURLUMYN | 1 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 1 | | 3 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50633-340-01 | 50633034001 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50633-340-01) / 1 mL in 1 VIAL, SINGLE-DOSE | 2025-08-01 | No | No | Current |