Prescription drug · ANDA
Fluvoxamine maleate extended-release NDC 70710-1848
Fluvoxamine maleate 150 mg/1 · Capsule, Extended release · Oral · Zydus Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70710-1848-3 | 7071018480370710184803 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70710-1848-3)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 — 150 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Zydus Pharmaceuticals USA Inc.NDC labeler code 70710
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 220447
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 70710-1848_cba28687-9ade-400c-9d15-c7de1d2113beSPL ID cba28687-9ade-400c-9d15-c7de1d2113beSPL set ID 6c71d4f6-54b5-4d3a-8d2f-b7773c92c32eRxCUI 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
N470710184803followed by a unit qualifier and the quantityPackage 70710-1848-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD) ( 1 ). Efficacy was demonstrated in: One 12-week study with fluvoxamine maleate extended-release capsules in adults ( 14.1 ) . Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents ( 14.1 , 14.3 ) . One maintenance study with IR fluvoxamine tablets ( 14.2 ) . 1.1 Obsessive Compulsive Disorder Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM…
Excerpt only. Read the full label for complete information.
About NDC 70710-1848
- What is NDC 70710-1848?
- 70710-1848 is the product NDC for Fluvoxamine maleate extended-release, Fluvoxamine maleate 150 mg/1 capsule, extended release, listed with the FDA by Zydus Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluvoxamine maleate extended-release.
- What is the active ingredient?
- Fluvoxamine maleate.
- Who is the labeler?
- Zydus Pharmaceuticals USA Inc., NDC labeler code 70710. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fluvoxamine maleate extended-release?
- 3 other product NDCs are listed under this name. See all Fluvoxamine maleate extended-release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fluvoxamine maleate extended-release products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fluvoxamine maleate extended-release | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1847 | 70710-1847-03 |
| Fluvoxamine maleate extended-release | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1957 | 70771-1957-03 |
| Fluvoxamine maleate extended-release | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1958 | 70771-1958-03 |
Other NDCs under ANDA 220447
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluvoxamine maleate extended-release | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Zydus Pharmaceuticals USA Inc. | 70710-1847 |
| Fluvoxamine maleate extended-release | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1957 |
| Fluvoxamine maleate extended-release | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Zydus Lifesciences Limited | 70771-1958 |