Prescription drug · ANDA
Anastrozole NDC 42291-016
Anastrozole 1 mg/1 · Tablet · Oral · AvKARE
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42291-016-30 | 4229100163042291001630 | 30 TABLET in 1 BOTTLE (42291-016-30)Marketed from Feb 6, 2023 | |
| 42291-016-90 | 4229100169042291001690 | 90 TABLET in 1 BOTTLE (42291-016-90)Marketed from Feb 6, 2023 |
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
- AvKARENDC labeler code 42291
- 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 42291-016_48481e73-92ad-d506-e063-6394a90a6518SPL ID 48481e73-92ad-d506-e063-6394a90a6518SPL set ID f40b925f-9f43-321d-e053-2a95a90aca8bRxCUI 199224UNII 2Z07MYW1AZUPC 0342291016309, 0342291016903
- 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
N442291001630followed by a unit qualifier and the quantityPackage 42291-0016-30. 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.
About NDC 42291-016
- What is NDC 42291-016?
- 42291-016 is the product NDC for Anastrozole, Anastrozole 1 mg/1 tablet, listed with the FDA by AvKARE. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Anastrozole.
- What is the active ingredient?
- Anastrozole.
- Who is the labeler?
- AvKARE, NDC labeler code 42291. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Anastrozole?
- 38 other product NDCs are listed under this name. See all Anastrozole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Anastrozole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-682 | 72189-0682-30 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-575 | 72789-0575-1572789-0575-30 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Upsher-Smith Laboratories, LLC | 24979-725 | 24979-0725-0624979-0725-07 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-415 | 72189-0415-30 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-236 | 59651-0236-3059651-0236-90 |
| Anastrozole | Anastrozole 1 mg/1 | Tablet, Film coatedOral | AvKARE | 42291-085 | 42291-0085-3042291-0085-90 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | AvPAK | 50268-075 | 50268-0075-15 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | Avet Pharmaceuticals Inc | 23155-857 | 23155-0857-0323155-0857-0523155-0857-09 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Chartwell RX, LLC | 62135-490 | 62135-0490-3062135-0490-90 |
| Anastrozoleanastrozole tablets | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3999 | 68071-3999-03 |
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 | PD-Rx Pharmaceuticals, Inc. | 43063-383 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | A-S Medication Solutions | 50090-5002 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | AvPAK | 50268-075 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Breckenridge Pharmaceutical, Inc. | 51991-620 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Natco Pharma Limited | 63850-0010 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-3838 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3853 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4038 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1879 |