Fluvoxamine maleate extended-release NDC 70771-1957

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1957Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1957Add 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
70771-1957-3	70771195703	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70771-1957-3)Marketed from Aug 4, 2026

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): Fluvoxamine maleate extended-release
Generic name (nonproprietary): fluvoxamine maleate extended-release
Active ingredients: Fluvoxamine maleate — 100 mg/1
Dosage form: Capsule, Extended release
Route: Oral
Labeler: Zydus Lifesciences Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220447
Marketing start: Aug 4, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Serotonin Uptake Inhibitors (Mechanism)
Identifiers: Product ID 70771-1957_d45aa001-af6b-41f2-ac88-c72411621202SPL ID d45aa001-af6b-41f2-ac88-c72411621202SPL set ID 1f172569-9110-44df-acc5-0367e37ed784RxCUI 903873, 903879UNII 5LGN83G74V
Pharmacologic class: Serotonin Reuptake Inhibitor

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

N470771195703 followed by a unit qualifier and the quantity

Package 70771-1957-03. 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 22, 2026.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 220447

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

FDA NDC Directory listings under ANDA 220447
Product	Strength	Form · route	Labeler	Product NDC
Fluvoxamine maleate extended-release	Fluvoxamine maleate 150 mg/1	Capsule, Extended releaseOral	Zydus Lifesciences Limited	70771-1958
Fluvoxamine maleate extended-release	Fluvoxamine maleate 100 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1847
Fluvoxamine maleate extended-release	Fluvoxamine maleate 150 mg/1	Capsule, Extended releaseOral	Zydus Pharmaceuticals USA Inc.	70710-1848