Prescription drug · ANDA
Trimipramine Maleate NDC 72162-2062
Trimipramine maleate 50 mg/1 · Capsule · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2062-3 | 72162206203 | 30 CAPSULE in 1 BOTTLE (72162-2062-3)Marketed from Jun 14, 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)
- Trimipramine Maleate
- Generic name (nonproprietary)
- trimipramine maleate
- Active ingredients
- Trimipramine maleate — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077361
- Marketing start
- Listing expires
- Identifiers
- Product ID 72162-2062_5407dfce-2ed0-48cd-af63-9a7d68545626SPL ID 5407dfce-2ed0-48cd-af63-9a7d68545626SPL set ID 326ef804-8d3a-425e-8513-8c9811856aa0RxCUI 313499UNII 269K6498LD
- Pharmacologic class
- Tricyclic Antidepressant
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
N472162206203followed by a unit qualifier and the quantityPackage 72162-2062-03. 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)
INDICATIONS AND USAGE Trimipramine Maleate Capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077361
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 |
|---|---|---|---|---|
| Trimipramine Maleate | Trimipramine maleate 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2063 |
| Trimipramine Maleate | Trimipramine maleate 25 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2061 |
| Trimipramine Maleate | Trimipramine maleate 100 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-852 |
| Trimipramine Maleate | Trimipramine maleate 25 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-850 |
| Trimipramine Maleate | Trimipramine maleate 50 mg/1 | CapsuleOral | Elite Laboratories, Inc. | 64850-851 |