Tamoxifen Citrate NDC 0378-0144

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-0144Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-0144Add 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
0378-0144-91	00378014491	60 TABLET in 1 BOTTLE (0378-0144-91)Marketed from Feb 20, 2004

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 074732
Marketing start: Feb 20, 2003
Marketing end: Apr 30, 2027
Other FDA classes: Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 0378-0144_715f7cf8-3937-41ca-bdbd-886dc713c975SPL ID 715f7cf8-3937-41ca-bdbd-886dc713c975SPL set ID 7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0RxCUI 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

N400378014491 followed by a unit qualifier and the quantity

Package 00378-0144-91. 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 Jul 2, 2021. 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 tablet therapy. Adjuvant Treatment of Breast Cancer Tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamo…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 074732

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

FDA NDC Directory listings under ANDA 074732
Product	Strength	Form · route	Labeler	Product NDC
Tamoxifen Citrate	Tamoxifen citrate 20 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-0274