Prescription drug · ANDA
Trazodone HCl NDC 80425-0176
Trazodone hydrochloride 50 mg/1 · Tablet · Oral · Advanced Rx Pharmacy of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0176-1 | 8042501760180425017601 | 30 TABLET in 1 BOTTLE (80425-0176-1)Marketed from Dec 11, 2017 | |
| 80425-0176-2 | 8042501760280425017602 | 60 TABLET in 1 BOTTLE (80425-0176-2)Marketed from Mar 31, 2023 |
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)
- Trazodone HCl
- Generic name (nonproprietary)
- trazodone hcl
- Active ingredients
- Trazodone hydrochloride — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanced Rx Pharmacy of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205253
- Marketing start
- Listing expires
- Identifiers
- Product ID 80425-0176_2a99a7c1-c4c3-2b01-e063-6294a90aa3b8SPL ID 2a99a7c1-c4c3-2b01-e063-6294a90aa3b8SPL set ID d27e4473-6f62-ddfe-e053-2a95a90a9a2cRxCUI 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
N480425017601followed by a unit qualifier and the quantityPackage 80425-0176-01. 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)
1. Indications and Usage Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
Excerpt only. Read the full label for complete information.
About NDC 80425-0176
- What is NDC 80425-0176?
- 80425-0176 is the product NDC for Trazodone HCl, Trazodone hydrochloride 50 mg/1 tablet, listed with the FDA by Advanced Rx Pharmacy of Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Trazodone HCl.
- What is the active ingredient?
- Trazodone hydrochloride.
- Who is the labeler?
- Advanced Rx Pharmacy of Tennessee, LLC, NDC labeler code 80425. 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 HCl?
- 2 other product NDCs are listed under this name. See all Trazodone HCl NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Trazodone HCl 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 HCL | Trazodone hydrochloride 50 mg/1 | TabletOral | Direct_Rx | 72189-694 | 72189-0694-3072189-0694-60 |
| Trazodone HCL | Trazodone hydrochloride 300 mg/1 | TabletOral | Direct_Rx | 72189-569 | 72189-0569-30 |
Other NDCs under ANDA 205253
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 100 mg/1 | TabletOral | American Health Packaging | 60687-454 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7943 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0730 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | A-S Medication Solutions | 50090-7944 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0742 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | NuCare Pharmaceuticals,Inc. | 68071-4410 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-154 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Proficient Rx LP | 71205-551 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-168 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-648 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7212 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8085 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-672 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1939 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-8087 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7118 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2180 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7137 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | TabletOral | Zydus Lifesciences Limited | 70771-1938 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-675 |
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