Prescription drug · ANDA
Anastrozole NDC 43063-383
Anastrozole 1 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-383-06 | 43063038306 | 6 TABLET in 1 BOTTLE, PLASTIC (43063-383-06)Marketed from Aug 23, 2018 | |
| 43063-383-15 | 43063038315 | 15 TABLET in 1 BOTTLE, PLASTIC (43063-383-15)Marketed from Aug 20, 2018 |
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
- PD-Rx 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 43063-383_5877c37c-7aad-e342-e063-6394a90a37eeSPL ID 5877c37c-7aad-e342-e063-6394a90a37eeSPL set ID 5d4f90d4-e535-4681-a863-3d774a2064e6RxCUI 199224UNII 2Z07MYW1AZUPC 0343063383155
- 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
N443063038306followed by a unit qualifier and the quantityPackage 43063-0383-06. 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 | NuCare Pharmaceuticals, Inc. | 68071-3853 |
| 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 | 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 |