Prescription drug · NDA
Etcamah (camizestrant) NDC 0310-0075
Camizestrant 75 mg/1 · Tablet, Film coated · Oral · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-0075-01 | 00310007501 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-01)Marketed from Sep 4, 2026 | |
| 0310-0075-95 | 00310007595 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0310-0075-95)Marketed from Sep 4, 2026 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Etcamah
- Generic name (nonproprietary)
- camizestrant
- Active ingredients
- Camizestrant — 75 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 220359
- Marketing start
- Listing expires
- Identifiers
- Product ID 0310-0075_c54223d3-f3c7-4186-afa0-429d84805826SPL ID c54223d3-f3c7-4186-afa0-429d84805826SPL set ID c54223d3-f3c7-4186-afa0-429d84805826RxCUI 2752687, 2752693UNII JUP57A8EPZUPC 0303100075016
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
N400310007501followed by a unit qualifier and the quantityPackage 00310-0075-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ETCAMAH in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) is indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test [see Dosage and Administration ( 2.1 )] . This indication is approved under accelerated approval based on progression-free survival as measured from detection of ESR1 mutation [see Clinical Studies ( 14 )] . Continued approval for this indication may be contingent upon verification and description of…
Excerpt only. Read the full label for complete information.