Prescription drug · ANDA
Exemestane NDC 71921-190
Exemestane 25 mg/1 · Tablet, Film coated · Oral · Florida Pharmaceutical Products, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71921-190-33 | 7192101903371921019033 | 30 TABLET, FILM COATED in 1 BOTTLE (71921-190-33)Marketed from Jan 15, 2021 |
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, Film coated
- Route
- Oral
- Labeler
- Florida Pharmaceutical Products, LLCNDC labeler code 71921
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213547
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 71921-190_28c7c528-d203-40c9-a06f-cbe4b0d73326SPL ID 28c7c528-d203-40c9-a06f-cbe4b0d73326SPL set ID 9354d1a1-8e8c-4c6a-b7ad-d4fe14b10a8bRxCUI 310261UNII NY22HMQ4BXUPC 0371921190331
- 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
N471921019033followed by a unit qualifier and the quantityPackage 71921-0190-33. 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 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 is 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…
Excerpt only. Read the full label for complete information.
About NDC 71921-190
- What is NDC 71921-190?
- 71921-190 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, film coated, listed with the FDA by Florida Pharmaceutical Products, LLC. 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?
- Florida Pharmaceutical Products, LLC, NDC labeler code 71921. 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 | 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 | 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 |