Prescription drug · ANDA
Trimipramine NDC 51991-944
Trimipramine maleate 25 mg/1 · Capsule · Oral · Breckenridge Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51991-944-01 | 51991094401 | 100 CAPSULE in 1 BOTTLE (51991-944-01)Marketed from Apr 5, 2017 | |
| 51991-944-33 | 51991094433 | 30 CAPSULE in 1 BOTTLE (51991-944-33)Marketed from Jun 11, 2019 |
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)
- Trimipramine
- Generic name (nonproprietary)
- trimipramine
- Active ingredients
- Trimipramine maleate — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208127
- Marketing start
- Listing expires
- Identifiers
- Product ID 51991-944_e1cadaf3-e932-4bfb-a8fa-57fb52f7dc67SPL ID e1cadaf3-e932-4bfb-a8fa-57fb52f7dc67SPL set ID 4f31df66-7dc2-1f04-e054-00144ff88e88RxCUI 313496, 313498, 313499UNII 269K6498LDUPC 0351991944331, 0351991946335, 0351991945338
- 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
N451991094401followed by a unit qualifier and the quantityPackage 51991-0944-01. 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)
INDICATIONS AND USAGE Trimipramine 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 208127
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 | Trimipramine maleate 50 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-945 |
| Trimipramine | Trimipramine maleate 100 mg/1 | CapsuleOral | Breckenridge Pharmaceutical, Inc. | 51991-946 |