Prescription drug · ANDA
Anastrozole (anastrozole tablets) NDC 82804-162
Anastrozole 1 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-162-30 | 82804016230 | 30 TABLET in 1 BOTTLE (82804-162-30)Marketed from Oct 25, 2024 | |
| 82804-162-90 | 82804016290 | 90 TABLET in 1 BOTTLE (82804-162-90)Marketed from Sep 16, 2025 |
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 tablets
- Active ingredients
- Anastrozole — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206037
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 82804-162_db39f10e-5444-4e57-97b2-0358001df04aSPL ID db39f10e-5444-4e57-97b2-0358001df04aSPL set ID 2df2aa01-1fe7-477c-9a23-699879b0b918RxCUI 199224UNII 2Z07MYW1AZUPC 0382804162307
- 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
N482804016230followed by a unit qualifier and the quantityPackage 82804-0162-30. 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)
Anastrozole is an aromatase inhibitor indicated for: • Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer ( Error! Hyperlink reference not valid. ) • First-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer ( Error! Hyperlink reference not valid. ) • 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 ( Error! Hyperlink reference not valid. ) 1.1 Adjuvant Treatment Anastr…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 206037
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 | Direct_Rx | 72189-682 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-490 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-725 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Avet Pharmaceuticals Inc | 23155-857 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3999 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-224 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Yiling Pharmaceutical, Inc. | 69117-0003 |