Prescription drug · ANDA
Tamoxifen Citrate NDC 50090-0942
Tamoxifen citrate 20 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-0942-0 | 50090094200 | 90 TABLET in 1 BOTTLE, PLASTIC (50090-0942-0)Marketed from Nov 28, 2014 |
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)
- Tamoxifen Citrate
- Generic name (nonproprietary)
- tamoxifen citrate
- Active ingredients
- Tamoxifen citrate — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 070929
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 50090-0942_7bfc1a17-2123-4f1b-bde7-cd6763ec10daSPL ID 7bfc1a17-2123-4f1b-bde7-cd6763ec10daSPL set ID 716657e8-d809-4671-87bc-8d10ef69a071RxCUI 313195UNII 7FRV7310N6
- Pharmacologic class
- Estrogen Agonist/Antagonist
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
N450090094200followed by a unit qualifier and the quantityPackage 50090-0942-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Metastatic Breast Cancer: Tamoxifen citrate tablets, USP are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets, USP are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen adjuvant studies, most of the…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 070929
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 |
|---|---|---|---|---|
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | TabletOral | Proficient Rx LP | 63187-976 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0485 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-2472 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-2473 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2225 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-5254 |