Prescription drug · ANDA
Anastrozole NDC 50090-2453
Anastrozole 1 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-2453-0 | 5009024530050090245300 | 30 TABLET in 1 BOTTLE, PLASTIC (50090-2453-0)Marketed from Aug 11, 2016 | |
| 50090-2453-1 | 5009024530150090245301 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-2453-1)Marketed from Jun 12, 2018 |
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
- A-S Medication SolutionsNDC labeler code 50090
- 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 50090-2453_ea40c7f6-80fd-4863-abf0-a5c4d64e4a81SPL ID ea40c7f6-80fd-4863-abf0-a5c4d64e4a81SPL set ID 03fb3108-1856-466d-bf88-0eac96139551RxCUI 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
N450090245300followed by a unit qualifier and the quantityPackage 50090-2453-00. 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.
About NDC 50090-2453
- What is NDC 50090-2453?
- 50090-2453 is the product NDC for Anastrozole, Anastrozole 1 mg/1 tablet, listed with the FDA by A-S Medication Solutions. 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?
- A-S Medication Solutions, NDC labeler code 50090. 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 | AvKARE | 42291-016 | 42291-0016-3042291-0016-90 |
| 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 |
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 | Accord Healthcare Inc. | 16729-035 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Proficient Rx LP | 63187-080 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-5269 |
| 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 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5203 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Direct_Rx | 72189-415 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-008 |
| Anastrozole | Anastrozole 1 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-004 |