Prescription drug · ANDA
Anastrozole NDC 16729-035
Anastrozole 1 mg/1 · Tablet · Oral · Accord Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16729-035-10 | 16729003510 | 30 TABLET in 1 BOTTLE, PLASTIC (16729-035-10)Marketed from Jun 22, 2010 | |
| 16729-035-15 | 16729003515 | 90 TABLET in 1 BOTTLE, PLASTIC (16729-035-15)Marketed from Feb 24, 2011 | |
| 16729-035-16 | 16729003516 | 500 TABLET in 1 BOTTLE, PLASTIC (16729-035-16)Marketed from Mar 21, 2011 |
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
- Accord Healthcare Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090568
- Marketing start
- Listing expires
- Other FDA classes
- Aromatase Inhibitors (Mechanism)
- Identifiers
- Product ID 16729-035_4a900d2c-12d3-6bfa-e063-6294a90af009SPL ID 4a900d2c-12d3-6bfa-e063-6294a90af009SPL set ID 03586c40-eb32-45c5-beb7-6762a6b78790RxCUI 199224UNII 2Z07MYW1AZUPC 0316729035101
- 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
N416729003510followed by a unit qualifier and the quantityPackage 16729-0035-10. 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 090568
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 | PD-Rx Pharmaceuticals, Inc. | 72789-008 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-415 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5203 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-004 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5269 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-2453 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Proficient Rx LP | 63187-080 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1543 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-1682 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-2791 |