Prescription drug · ANDA
Exemestane NDC 63629-2056
Exemestane 25 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-2056-1 | 63629205601 | 30 TABLET, FILM COATED in 1 BOTTLE (63629-2056-1)Marketed from Dec 19, 2019 |
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)
- Exemestane
- Generic name (nonproprietary)
- exemestane
- Active ingredients
- Exemestane — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211031
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 63629-2056_24b13a97-81f9-47f1-8c49-64e63ea12bd4SPL ID 24b13a97-81f9-47f1-8c49-64e63ea12bd4SPL set ID 1841ec12-3f4f-4b87-b719-fd0b4d9eaffbRxCUI 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
N463629205601followed by a unit qualifier and the quantityPackage 63629-2056-01. 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 .
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 tablets 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 …
Excerpt only. Read the full label for complete information.
About NDC 63629-2056
- What is NDC 63629-2056?
- 63629-2056 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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?
- 9 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, 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 | TabletOral | Zydus Lifesciences Limited | 70771-1374 | 70771-1374-03 |
| Exemestane | Exemestane 25 mg/1 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-383 | 68382-0383-06 |
| Exemestane | Exemestane 25 mg/1 | TabletOral | Cipla USA Inc. | 69097-316 | 69097-0316-02 |
| Exemestane | Exemestane 25 mg/1 | TabletOral | Upsher-Smith Laboratories, Inc. | 0832-0595 | 00832-0595-30 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Sugar coatedOral | Mylan Pharmaceuticals Inc. | 59762-2858 | 59762-2858-01 |
Other NDCs under ANDA 211031
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 |
|---|---|---|---|---|
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-005 |