Prescription drug · ANDA
Exemestane NDC 70771-1374
Exemestane 25 mg/1 · Tablet · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70771-1374-3 | 70771137403 | 30 TABLET in 1 BOTTLE (70771-1374-3)Marketed from Oct 8, 2018 |
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
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 70771
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202602
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 70771-1374_7892e262-ddad-4e1d-909d-d8590bb082deSPL ID 7892e262-ddad-4e1d-909d-d8590bb082deSPL set ID fab5468a-d5b7-45e3-b8b2-ed902fddd3a6RxCUI 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
N470771137403followed by a unit qualifier and the quantityPackage 70771-1374-03. 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 .
About NDC 70771-1374
- What is NDC 70771-1374?
- 70771-1374 is the product NDC for Exemestane, Exemestane 25 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. 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?
- Zydus Lifesciences Limited, NDC labeler code 70771. 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 | Bryant Ranch Prepack | 63629-2056 | 63629-2056-01 |
| Exemestane | Exemestane 25 mg/1 | Tablet, Film coatedOral | Breckenridge Pharmaceutical, Inc. | 51991-005 | 51991-0005-90 |
| 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 202602
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 | TabletOral | Zydus Pharmaceuticals USA Inc. | 68382-383 |