Prescription drug · ANDA
Anastrozole NDC 71335-3145
Anastrozole 1 mg/1 · Tablet, Coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-3145-0 | 71335314500 | 28 TABLET, COATED in 1 BOTTLE (71335-3145-0)Marketed from Jun 18, 2026 | |
| 71335-3145-1 | 71335314501 | 30 TABLET, COATED in 1 BOTTLE (71335-3145-1)Marketed from Jun 18, 2026 | |
| 71335-3145-2 | 71335314502 | 20 TABLET, COATED in 1 BOTTLE (71335-3145-2)Marketed from Jun 18, 2026 | |
| 71335-3145-3 | 71335314503 | 90 TABLET, COATED in 1 BOTTLE (71335-3145-3)Marketed from Jun 18, 2026 | |
| 71335-3145-4 | 71335314504 | 4 TABLET, COATED in 1 BOTTLE (71335-3145-4)Marketed from Jun 18, 2026 | |
| 71335-3145-5 | 71335314505 | 6 TABLET, COATED in 1 BOTTLE (71335-3145-5)Marketed from Jun 18, 2026 | |
| 71335-3145-6 | 71335314506 | 10 TABLET, COATED in 1 BOTTLE (71335-3145-6)Marketed from Jun 18, 2026 | |
| 71335-3145-7 | 71335314507 | 40 TABLET, COATED in 1 BOTTLE (71335-3145-7)Marketed from Jun 18, 2026 | |
| 71335-3145-8 | 71335314508 | 12 TABLET, COATED in 1 BOTTLE (71335-3145-8)Marketed from Jun 18, 2026 | |
| 71335-3145-9 | 71335314509 | 14 TABLET, COATED in 1 BOTTLE (71335-3145-9)Marketed from Jun 18, 2026 |
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, Coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078921
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 71335-3145_51d68c25-5310-4c4d-8c95-83e3c17815f3SPL ID 51d68c25-5310-4c4d-8c95-83e3c17815f3SPL set ID f5b53383-0366-4ae2-9aa4-88b56c0bbd07RxCUI 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
N471335314500followed by a unit qualifier and the quantityPackage 71335-3145-00. 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 ( 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 ( 1.3 ) 1.1 Adjuvant Treatment Anastrozole tablets are indicated for adjuvant treatment of postmenopausal women with hormone receptor-positive ea…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078921
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 | Tablet, CoatedOral | Zydus Lifesciences Limited | 65841-743 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, CoatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-342 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, CoatedOral | American Health Packaging | 60687-112 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, CoatedOral | BluePoint Laboratories | 68001-155 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, CoatedOral | Zydus Pharmaceuticals USA Inc. | 68382-209 |