Prescription drug · ANDA
Tamoxifen Citrate NDC 72162-2208
Tamoxifen citrate 10 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2208-6 | 72162220806 | 60 TABLET, FILM COATED in 1 BOTTLE (72162-2208-6)Marketed from Jan 5, 2024 |
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 — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213358
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 72162-2208_681529be-51fc-4ac3-902a-2e00beb327a9SPL ID 681529be-51fc-4ac3-902a-2e00beb327a9SPL set ID feb96056-79f5-4024-ab0e-fdbb8d4ab862RxCUI 198240UNII 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
N472162220806followed by a unit qualifier and the quantityPackage 72162-2208-06. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INDICATIONS AND USAGE Metastatic Breast Cancer: Tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen citrate tablets are 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 citrate tablets therapy. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets 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 citrat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 213358
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 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3990 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-299 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-300 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2209 |