Prescription drug · ANDA
Tranylcypromine NDC 70954-538
Tranylcypromine sulfate 10 mg/1 · Tablet · Oral · Novitium Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-538-10 | 70954053810 | 100 TABLET in 1 BOTTLE (70954-538-10)Marketed from Jun 6, 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)
- Tranylcypromine
- Generic name (nonproprietary)
- tranylcypromine
- Active ingredients
- Tranylcypromine sulfate — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Novitium Pharma LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206856
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 70954-538_8ab1c887-76fb-44ca-9999-4eefd3778cfcSPL ID 8ab1c887-76fb-44ca-9999-4eefd3778cfcSPL set ID 8ab1c887-76fb-44ca-9999-4eefd3778cfcRxCUI 313447UNII 7ZAT6ES870UPC 0370954538103
- Pharmacologic class
- Monoamine Oxidase 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
N470954053810followed by a unit qualifier and the quantityPackage 70954-0538-10. 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)
Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are not indicated for the initial treatment of MDD due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [see Contraindications (4), Warnings and Precautions (5), and Drug Interactions (7)] . Tranylcypromine tablets are a monoamine oxidase inhibitor (MAOI) indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants (1) Tranylcypromine tablets are not indicated for th…
Excerpt only. Read the full label for complete information.