Prescription drug · ANDA
Anastrozole NDC 68071-3853
Anastrozole 1 mg/1 · Tablet · Oral · NuCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-3853-7 | 68071385307 | 12 TABLET in 1 BOTTLE (68071-3853-7)Marketed from Dec 9, 2025 | |
| 68071-3853-8 | 68071385308 | 8 TABLET in 1 BOTTLE (68071-3853-8)Marketed from May 27, 2025 |
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)
- Anastrozole
- Generic name (nonproprietary)
- anastrozole
- Active ingredients
- Anastrozole — 1 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals, Inc.
- 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 68071-3853_4587a0ae-889c-26c8-e063-6394a90adb3fSPL ID 4587a0ae-889c-26c8-e063-6394a90adb3fSPL set ID 362034e9-2830-19a5-e063-6394a90a8dfbRxCUI 199224UNII 2Z07MYW1AZUPC 0368071385380
- 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
N468071385307followed by a unit qualifier and the quantityPackage 68071-3853-07. 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 | 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 | AvPAK | 50268-075 |
| 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 |