ORSERDU
- Product NDC
- 72187-0102
- 11-digit product format
- 721870102
- Labeler code
- 72187
- Product ID
- 72187-0102_42ec5c9c-8984-4561-a4eb-c6ddc916c18a
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Elacestrant
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Stemline Therapeutics, Inc.
- Application
- NDA217639
- Marketing category
- NDA
- Marketing start
- 2023-01-27
- Substance
- ELACESTRANT
- Active strength
- 345 mg/1
- Pharmacologic classes
- Breast Cancer Resistance Protein Inhibitors [MoA], Estrogen Receptor Antagonist [EPC], Estrogen Receptor Antagonists [MoA], P-Glycoprotein Inhibitors [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORSERDU
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ELACESTRANT | 345 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | FM6A2627A8 |
| Rxcui | 2628478, 2628484, 2628487, 2628489 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72187-0102-3 | ORSERDU | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72187-0102 | ORSERDU (ELACESTRANT) TABLET, FILM COATED [STEMLINE THERAPEUTICS, INC.] | 5 | Current NDC, 1 package rows | 20240805_aa66ae5c-2bd2-4444-8178-b55651e054ef.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 72187-0102-3 | 72187010203 | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3) | 2023-01-27 | No | No | Historical |