Prescription drug · ANDA
Fluvoxamine Maleate NDC 10370-176
Fluvoxamine maleate 150 mg/1 · Capsule, Extended release · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10370-176-11 | 1037001761110370017611 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10370-176-11)Marketed from Mar 13, 2013 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Fluvoxamine Maleate
- Generic name (nonproprietary)
- fluvoxamine maleate
- Active ingredients
- Fluvoxamine maleate — 150 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 10370
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091476
- Marketing start
- Listing expires
- Other FDA classes
- Serotonin Uptake Inhibitors (Mechanism)
- Identifiers
- Product ID 10370-176_26cb8a8c-1b8a-4f72-b0c2-218b83098116SPL ID 26cb8a8c-1b8a-4f72-b0c2-218b83098116SPL set ID d492230c-f56a-4759-ba86-7090b9f44063RxCUI 903873, 903879UNII 5LGN83G74VUPC 0310370175117, 0310370176114
- 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
N410370017611followed by a unit qualifier and the quantityPackage 10370-0176-11. 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 DS…
Excerpt only. Read the full label for complete information.
About NDC 10370-176
- What is NDC 10370-176?
- 10370-176 is the product NDC for Fluvoxamine Maleate, Fluvoxamine maleate 150 mg/1 capsule, extended release, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluvoxamine Maleate.
- What is the active ingredient?
- Fluvoxamine maleate.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 10370. 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?
- 37 other product NDCs are listed under this name. See all Fluvoxamine Maleate 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 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 | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-6026 | 00832-6026-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Upsher-Smith Laboratories, LLC | 0832-6025 | 00832-6025-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-066 | 73190-0066-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | AvKARE | 73190-067 | 73190-0067-30 |
| Fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4011 | 68788-4011-0368788-4011-0668788-4011-09 |
| Fluvoxamine Maleate | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-064 | 31722-0064-0131722-0064-30 |
| Fluvoxamine Maleate | Fluvoxamine maleate 150 mg/1 | Capsule, Extended releaseOral | Camber Pharmaceuticals, Inc. | 31722-065 | 31722-0065-0131722-0065-30 |
| Fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7728 | 50090-7728-00 |
| Fluvoxamine maleate | Fluvoxamine maleate 25 mg/1 | TabletOral | Bionpharma Inc. | 69452-454 | 69452-0454-2069452-0454-3069452-0454-32 |
| Fluvoxamine maleate | Fluvoxamine maleate 100 mg/1 | TabletOral | Bionpharma Inc. | 69452-455 | 69452-0455-2069452-0455-3069452-0455-32 |
Other NDCs under ANDA 091476
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 | Fluvoxamine maleate 100 mg/1 | Capsule, Extended releaseOral | Par Health USA, LLC | 10370-175 |