Tamoxifen Citrate NDC 51862-643

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-643Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0643Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
51862-643-10	51862064310	1000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10)Marketed from Aug 27, 2021
51862-643-30	51862064330	30 TABLET, FILM COATED in 1 BOTTLE (51862-643-30)Marketed from Aug 27, 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): Tamoxifen Citrate
Generic name (nonproprietary): tamoxifen citrate
Active ingredients: Tamoxifen citrate — 20 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Mayne Pharma Commercial LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075797
Marketing start: Aug 27, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 51862-643_433f16e8-7df7-8a6e-e063-6394a90a7c4cSPL ID 433f16e8-7df7-8a6e-e063-6394a90a7c4cSPL set ID c82205a3-ae0c-4ce5-b04b-9581cd8c70d4RxCUI 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

N451862064310 followed by a unit qualifier and the quantity

Package 51862-0643-10. 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 Nov 10, 2025. 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 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 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 benefit to …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 075797

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 075797
Product	Strength	Form · route	Labeler	Product NDC
Tamoxifen Citrate	Tamoxifen citrate 10 mg/1	Tablet, Film coatedOral	Dr. Reddy's Labratories Inc.	75907-058
Tamoxifen Citrate	Tamoxifen citrate 20 mg/1	Tablet, Film coatedOral	Dr. Reddy's Labratories Inc.	75907-059