Prescription drug · ANDA
Tamoxifen Citrate NDC 59651-300
Tamoxifen citrate 20 mg/1 · Tablet, Film coated · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-300-30 | 5965103003059651030030 | 30 TABLET, FILM COATED in 1 BOTTLE (59651-300-30)Marketed from Aug 14, 2020 | |
| 59651-300-90 | 5965103009059651030090 | 90 TABLET, FILM COATED in 1 BOTTLE (59651-300-90)Marketed from Aug 14, 2020 |
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)
- Tamoxifen Citrate
- Generic name (nonproprietary)
- tamoxifen citrate
- Active ingredients
- Tamoxifen citrate — 20 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- 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 59651-300_a596c715-8e30-43c1-aba3-4fe5de6729faSPL ID a596c715-8e30-43c1-aba3-4fe5de6729faSPL set ID a596c715-8e30-43c1-aba3-4fe5de6729faRxCUI 198240, 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
N459651030030followed by a unit qualifier and the quantityPackage 59651-0300-30. 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 . 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.
About NDC 59651-300
- What is NDC 59651-300?
- 59651-300 is the product NDC for Tamoxifen Citrate, Tamoxifen citrate 20 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tamoxifen Citrate.
- What is the active ingredient?
- Tamoxifen citrate.
- Who is the labeler?
- Aurobindo Pharma Limited, NDC labeler code 59651. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tamoxifen Citrate?
- 16 other product NDCs are listed under this name. See all Tamoxifen Citrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Tamoxifen Citrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Labratories Inc. | 75907-058 | 75907-0058-1075907-0058-60 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | Tablet, Film coatedOral | Dr. Reddy's Labratories Inc. | 75907-059 | 75907-0059-1075907-0059-30 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | Tablet, Film coatedOral | Mayne Pharma Commercial LLC | 51862-643 | 51862-0643-1051862-0643-30 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 59651-299 | 59651-0299-60 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3990 | 68071-3990-03 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2208 | 72162-2208-06 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2209 | 72162-2209-03 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-2472 | 00591-2472-1800591-2472-60 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | TabletOral | Actavis Pharma, Inc. | 0591-2473 | 00591-2473-1900591-2473-30 |
| Tamoxifen Citrate | Tamoxifen citrate 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-0485 | 50090-0485-01 |
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 | Aurobindo Pharma Limited | 59651-299 |
| 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 | Bryant Ranch Prepack | 72162-2208 |
| Tamoxifen Citrate | Tamoxifen citrate 20 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 72162-2209 |