Prescription drug · NDA
Parnate (tranylcypromine sulfate) NDC 59212-447
Tranylcypromine sulfate 10 mg/1 · Tablet, Film coated · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-447-10 | 59212044710 | 100 TABLET, FILM COATED in 1 BOTTLE (59212-447-10)Marketed from Jan 14, 2013 |
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)
- Parnate
- Generic name (nonproprietary)
- tranylcypromine sulfate
- Active ingredients
- Tranylcypromine sulfate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 012342
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 59212-447_1e311326-d555-4a01-91a5-f53077a450c4SPL ID 1e311326-d555-4a01-91a5-f53077a450c4SPL set ID b72d8187-dfcc-4ea0-b5e9-c0be95b69a27RxCUI 104838, 313447UNII 7ZAT6ES870
- 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
N459212044710followed by a unit qualifier and the quantityPackage 59212-0447-10. 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)
PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE is 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) ] . PARNATE is 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) PARNATE is not indicated for the initial treatment of MDD due to the potential for serious adve…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 012342
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 |
|---|---|---|---|---|
| Tranylcypromine Sulfate | Tranylcypromine sulfate 10 mg/1 | Tablet, Film coatedOral | Actavis Pharma, Inc. | 0591-5590 |