Prescription drug · ANDA
Trazodone Hydrochloride NDC 71610-513
Trazodone hydrochloride 100 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-513-30 | 7161005133071610051330 | 30 TABLET in 1 BOTTLE (71610-513-30)Marketed from Jan 6, 2021 | |
| 71610-513-60 | 7161005136071610051360 | 90 TABLET in 1 BOTTLE (71610-513-60)Marketed from Jan 4, 2021 | |
| 71610-513-80 | 7161005138071610051380 | 180 TABLET in 1 BOTTLE (71610-513-80)Marketed from Feb 12, 2021 |
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)
- Trazodone Hydrochloride
- Generic name (nonproprietary)
- trazodone hydrochloride
- Active ingredients
- Trazodone hydrochloride — 100 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 071196
- Marketing start
- Listing expires
- Identifiers
- Product ID 71610-513_7309a57d-a286-4cde-82fe-5a84f5823572SPL ID 7309a57d-a286-4cde-82fe-5a84f5823572SPL set ID 5d22a06c-9cb8-4b49-8d67-769d181ad70cRxCUI 856373, 856377UNII 6E8ZO8LRNM
- 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
N471610051330followed by a unit qualifier and the quantityPackage 71610-0513-30. 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)
Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. Trazodone hydrochloride tablets are is a selective serotonin reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 71610-513
- What is NDC 71610-513?
- 71610-513 is the product NDC for Trazodone Hydrochloride, Trazodone hydrochloride 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trazodone Hydrochloride.
- What is the active ingredient?
- Trazodone hydrochloride.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Trazodone Hydrochloride?
- 157 other product NDCs are listed under this name. See all Trazodone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trazodone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | American Health Packaging | 60687-965 | 60687-0965-01 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4760 | 70518-4760-0070518-4760-0270518-4760-03+1 more |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-116 | 82868-0116-90 |
| Trazodone Hydrochloride | Trazodone hydrochloride 25 mg/1 | Tablet, Film coatedOral | TRUPHARMA LLC | 52817-395 | 52817-0395-10 |
| Trazodone Hydrochloride | Trazodone hydrochloride 75 mg/1 | Tablet, Film coatedOral | TRUPHARMA LLC | 52817-396 | 52817-0396-10 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4737 | 70518-4737-0070518-4737-01 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | American Health Packaging | 60687-954 | 60687-0954-01 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-080 | 87441-0080-01 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-081 | 87441-0081-01 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1684 | 67046-1684-03 |
Other NDCs under ANDA 071196
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 |
|---|---|---|---|---|
| Trazodone Hydrochloride | Trazodone hydrochloride 300 mg/1 | TabletOral | Teva Pharmaceuticals USA, Inc. | 0555-0711 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Apotex Corp | 60505-2654 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Apotex Corp | 60505-2655 |
| Trazodone Hydrochloride | Trazodone hydrochloride 300 mg/1 | TabletOral | Apotex Corp | 60505-2659 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3403 |