Prescription drug · ANDA
Trazodone Hydrochloride NDC 57664-014
Trazodone hydrochloride 50 mg/1 · Tablet, Film coated · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57664-014-72 | 5766400147257664001472 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-72)Marketed from Oct 3, 2022 | |
| 57664-014-74 | 5766400147457664001474 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-74)Marketed from Oct 3, 2022 | |
| 57664-014-75 | 5766400147557664001475 | 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (57664-014-75)Marketed from Oct 3, 2022 |
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 — 50 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 57664
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 073137
- Marketing start
- Listing expires
- Identifiers
- Product ID 57664-014_323e3d63-4d8d-7088-e063-6294a90abb0fSPL ID 323e3d63-4d8d-7088-e063-6294a90abb0fSPL set ID f291b905-a739-5e43-e053-2995a90ac40cRxCUI 856364, 856373, 856377UNII 6E8ZO8LRNMUPC 0357664014721
- 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
N457664001472followed by a unit qualifier and the quantityPackage 57664-0014-72. 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 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 57664-014
- What is NDC 57664-014?
- 57664-014 is the product NDC for Trazodone Hydrochloride, Trazodone hydrochloride 50 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. 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?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 57664. 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 073137
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 | Tablet, Film coatedOral | Sun Pharmaceutical Industries, Inc. | 57664-026 |
| Trazodone Hydrochloride | Trazodone hydrochloride 150 mg/1 | TabletOral | Sun Pharmaceutical Industries, Inc. | 57664-053 |
| Trazodone Hydrochloride | Trazodone hydrochloride 100 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1662 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1684 |
| Trazodone Hydrochloride | Trazodone hydrochloride 50 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-4363 |