Prescription drug · ANDA
Exemestane NDC 69097-316
Exemestane 25 mg/1 · Tablet · Oral · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-316-02 | 69097031602 | 30 TABLET in 1 BOTTLE (69097-316-02)Marketed from Apr 27, 2018 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Exemestane
- Generic name (nonproprietary)
- exemestane
- Active ingredients
- Exemestane — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Cipla USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210323
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 69097-316_60b57295-ef43-4721-94c4-58a4c5689420SPL ID 60b57295-ef43-4721-94c4-58a4c5689420SPL set ID abde1ccd-0ec9-40d4-b205-fbc00f5878b9RxCUI 310261UNII NY22HMQ4BX
- Pharmacologic class
- Aromatase Inhibitor
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
N469097031602followed by a unit qualifier and the quantityPackage 69097-0316-02. 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)
Exemestane is an aromatase inhibitor indicated for: adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane tablets, USP for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1 ). treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2 ). 1.1 Adjuvant Treatment of Postmenopausal Women Exemestane tablets, USP are indicated for adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are…
Excerpt only. Read the full label for complete information.