Prescription drug · ANDA
Anastrozole NDC 50268-075
Anastrozole 1 mg/1 · Tablet · Oral · AvPAK
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50268-075-15 | 50268007515 | 50 BLISTER PACK in 1 BOX (50268-075-15) / 1 TABLET in 1 BLISTER PACK (50268-075-11)Marketed from Oct 11, 2019 |
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)
- Anastrozole
- Generic name (nonproprietary)
- anastrozole
- Active ingredients
- Anastrozole — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- AvPAK
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079220
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 50268-075_4cb0acb4-c462-984f-e063-6294a90abe7cSPL ID 4cb0acb4-c462-984f-e063-6294a90abe7cSPL set ID 94a46579-0d79-89c7-e053-2995a90a6467RxCUI 199224UNII 2Z07MYW1AZ
- 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
N450268007515followed by a unit qualifier and the quantityPackage 50268-0075-15. 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)
Anastrozole tablets are an aromatase inhibitor indicated for: Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( 1.1 ) First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( 1.2 ) Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with ER-negative disease and patients who did not respond to previous tamoxifen therapy rarely responded to anastrozole tablets ( 1.3 ) 1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone rec…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 079220
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 |
|---|---|---|---|---|
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-620 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | AvKARE | 42291-016 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3853 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Natco Pharma Limited | 63850-0010 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1879 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 43063-383 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5002 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4038 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3838 |