Prescription drug · NDA
Orserdu (Elacestrant) NDC 72187-0102
Elacestrant 345 mg/1 · Tablet, Film coated · Oral · Stemline Therapeutics, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72187-0102-3 | 72187010203 | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3)Marketed from Jan 27, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Orserdu
- Generic name (nonproprietary)
- elacestrant
- Active ingredients
- Elacestrant — 345 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Stemline Therapeutics, Inc.NDC labeler code 72187
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217639
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Estrogen Receptor Antagonists (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 72187-0102_040abaf0-7a15-11f1-b55a-0800200c9a66SPL ID 040abaf0-7a15-11f1-b55a-0800200c9a66SPL set ID aa66ae5c-2bd2-4444-8178-b55651e054efRxCUI 2628478, 2628484, 2628487, 2628489UNII FM6A2627A8UPC 0372187010135, 0372187010234
- Pharmacologic class
- Estrogen Receptor Antagonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N472187010203followed by a unit qualifier and the quantityPackage 72187-0102-03. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
ORSERDU is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)‑negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test [see Dosage and Administration ( 2.1 )] , with disease progression following at least one line of endocrine therapy. ORSERDU is an estrogen receptor antagonist indicated for: treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy ( 1 )…
Excerpt only. Read the full label for complete information.
About NDC 72187-0102
- What is NDC 72187-0102?
- 72187-0102 is the product NDC for Orserdu (elacestrant), Elacestrant 345 mg/1 tablet, film coated, listed with the FDA by Stemline Therapeutics, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Orserdu (Elacestrant).
- What is the active ingredient?
- Elacestrant.
- Who is the labeler?
- Stemline Therapeutics, Inc., NDC labeler code 72187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Orserdu?
- 1 other product NDC are listed under this name. See all Orserdu NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Orserdu products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Orserduelacestrant | Elacestrant 86 mg/1 | Tablet, Film coatedOral | Stemline Therapeutics, Inc. | 72187-0101 | 72187-0101-03 |
Other NDCs under NDA 217639
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Orserduelacestrant | Elacestrant 86 mg/1 | Tablet, Film coatedOral | Stemline Therapeutics, Inc. | 72187-0101 |