Fulvestrant NDC 70121-1463

NDC codes

FDA NDC Directory

Product NDC (as listed)70121-1463Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70121-1463Add 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
70121-1463-2	70121146302	2 SYRINGE, GLASS in 1 CARTON (70121-1463-2) / 5 mL in 1 SYRINGE, GLASS (70121-1463-3)Marketed from Mar 4, 2019

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): Fulvestrant
Generic name (nonproprietary): fulvestrant
Active ingredients: Fulvestrant — 250 mg/5mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Amneal Pharmaceuticals LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210044
Marketing start: Mar 4, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 70121-1463_84f58921-6fc9-4f8c-b074-a716239e52e2SPL ID 84f58921-6fc9-4f8c-b074-a716239e52e2SPL set ID f36f19ad-f044-4dba-80b6-d074ddffcd86RxCUI 727762UNII 22X328QOC4
Pharmacologic class: Estrogen Receptor 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N470121146302 followed by a unit qualifier and the quantity

Package 70121-1463-02. 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 May 30, 2025.

Indications (excerpt from the label)

Monotherapy Fulvestrant injection is indicated for the treatment of: Hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy, or HR-positive advanced breast cancer in postmenopausal women with disease progression following endocrine therapy. Combination Therapy Fulvestrant injection is indicated for the treatment of: HR-positive, HER2-negative advanced or metastatic breast cancer in postmenopausal women in combination with ribociclib as initial endocrine based therapy or following disease progression on endocrine therapy. HR-positive, HER2-negative advanced or metasta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210044

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

FDA NDC Directory listings under ANDA 210044
Product	Strength	Form · route	Labeler	Product NDC
Fulvestrant	Fulvestrant 250 mg/5mL	Injection, SolutionIntramuscular	BluePoint Laboratories	68001-484