Prescription drug · NDA
Soltamox (tamoxifen citrate) NDC 51862-682
Tamoxifen citrate 20 mg/10mL · Liquid · Oral · Mayne Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-682-00 | 51862068200 | 1 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINERMarketed from Dec 6, 2021 | |
| 51862-682-01 | 51862068201 | 1 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINERMarketed from Jun 18, 2021 |
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)
- Soltamox
- Generic name (nonproprietary)
- tamoxifen citrate
- Active ingredients
- Tamoxifen citrate — 20 mg/10mL
- Dosage form
- Liquid
- Route
- Oral
- Labeler
- Mayne Pharma
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021807
- Marketing start
- Listing expires
- Other FDA classes
- Selective Estrogen Receptor Modulators (Mechanism)
- Identifiers
- Product ID 51862-682_5bcbc281-342c-4b05-8409-53a08b1fc9f6SPL ID 5bcbc281-342c-4b05-8409-53a08b1fc9f6SPL set ID 1e6ff055-590c-41e6-9530-1fdf04cdbd02RxCUI 389230, 644304UNII 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
N451862068200followed by a unit qualifier and the quantityPackage 51862-0682-00. 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)
SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer ( 1.1 ) For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer ( 1.2 ) To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS) ( 1.3 ) To reduce the incidence of breast cancer in adult women at high risk ( 1.4 ) 1.1 Metastatic Breast Cancer SOLTAMOX is indicated for the treatment of adult patients with estrogen receptor-positive metastatic breast cancer. 1.2 Adjuvant Treatment of Breast Cancer SOLTAMOX is indicated: for the adjuvant…
Excerpt only. Read the full label for complete information.