Fulvestrant NDC 70771-1626

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1626Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1626Add 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
70771-1626-8	70771162608	2 SYRINGE, GLASS in 1 CARTON (70771-1626-8) / 5 mL in 1 SYRINGE, GLASS (70771-1626-2)Marketed from Dec 14, 2021

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 — 50 mg/mL
Dosage form: Injection, Solution
Route: Intramuscular
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 215234
Marketing start: Dec 14, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Estrogen Receptor Antagonists (Mechanism)Selective Estrogen Receptor Modulators (Mechanism)
Identifiers: Product ID 70771-1626_6908877d-222b-43e6-a7e9-f264fae84be4SPL ID 6908877d-222b-43e6-a7e9-f264fae84be4SPL set ID 151b948a-3106-497a-b1c7-479307faeb89RxCUI 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

N470771162608 followed by a unit qualifier and the quantity

Package 70771-1626-08. 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 Aug 26, 2022.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 215234

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

FDA NDC Directory listings under ANDA 215234
Product	Strength	Form · route	Labeler	Product NDC
Fulvestrant	Fulvestrant 50 mg/mL	Injection, SolutionIntramuscular	Zydus Pharmaceuticals USA Inc.	70710-1688