Prescription drug · ANDA
Exemestane NDC 0832-0595
Exemestane 25 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0832-0595-30 | 00832059530 | 30 TABLET in 1 BOTTLE (0832-0595-30)Marketed from Jul 27, 2017 |
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)
- Exemestane
- Generic name (nonproprietary)
- exemestane
- Active ingredients
- Exemestane — 25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, Inc.NDC labeler code 0832
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209208
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 0832-0595_2f12eda2-6bae-041a-e063-6294a90ac968SPL ID 2f12eda2-6bae-041a-e063-6294a90ac968SPL set ID f8bd17b4-5289-45bb-8095-de89dc8d39edRxCUI 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
N400832059530followed by a unit qualifier and the quantityPackage 00832-0595-30. 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 tablets are 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 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 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 switched…
Excerpt only. Read the full label for complete information.
About NDC 0832-0595
- What is NDC 0832-0595?
- 0832-0595 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Exemestane.
- What is the active ingredient?
- Exemestane.
- Who is the labeler?
- Upsher-Smith Laboratories, Inc., NDC labeler code 0832. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Exemestane?
- 10 other product NDCs are listed under this name. See all Exemestane NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Exemestane products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Exemestane | Exemestane 25 mg/1 | Tablet, CoatedOral | OPKO Pharmaceuticals, LLC | 70301-2017 | 70301-2017-01 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | NorthStar Rx LLC | 72603-329 | 72603-0329-01 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-516 | 59651-0516-30 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | Florida Pharmaceutical Products, LLC | 71921-190 | 71921-0190-33 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-005 | 51991-0005-90 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-2056 | 63629-2056-01 |
| Exemestane | Exemestane 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-383 | 68382-0383-06 |
| Exemestane | Exemestane 25 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1374 | 70771-1374-03 |
| Exemestane | Exemestane 25 mg/1 | TabletOral | Cipla USA Inc. | 69097-316 | 69097-0316-02 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Sugar coatedOral | Mylan Pharmaceuticals Inc. | 59762-2858 | 59762-2858-01 |