Prescription drug · ANDA
Anastrozole NDC 63850-0010
Anastrozole 1 mg/1 · Tablet · Oral · Natco Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63850-0010-1 | 63850001001 | 30 TABLET in 1 BOTTLE (63850-0010-1)Marketed from Jun 28, 2010 | |
| 63850-0010-2 | 63850001002 | 1000 TABLET in 1 BOTTLE (63850-0010-2)Marketed from Jun 28, 2010 |
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
- Natco Pharma Limited
- 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 63850-0010_605b2a4c-1f1d-473d-a911-133ca46f0538SPL ID 605b2a4c-1f1d-473d-a911-133ca46f0538SPL set ID df55dc4c-9a53-4a37-a90f-c4e88d458b89RxCUI 199224UNII 2Z07MYW1AZUPC 0363850001024, 0363850001017
- 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
N463850001001followed by a unit qualifier and the quantityPackage 63850-0010-01. 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 aromatase inhibitors 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 recep…
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 | 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 |