Prescription drug · NDA AUTHORIZED GENERIC
Tranylcypromine Sulfate NDC 0591-5590
Tranylcypromine sulfate 10 mg/1 · Tablet, Film coated · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-5590-01 | 00591559001 | 100 TABLET, FILM COATED in 1 BOTTLE (0591-5590-01)Marketed from Feb 5, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 Sulfate
- Generic name (nonproprietary)
- tranylcypromine sulfate
- Active ingredients
- Tranylcypromine sulfate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 012342
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0591-5590_e42c8b23-863e-4370-a3b1-b71526b12ee5SPL ID e42c8b23-863e-4370-a3b1-b71526b12ee5SPL set ID 6a0b609b-0625-4c26-91a1-59ee3ece3ddfRxCUI 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
N400591559001followed by a unit qualifier and the quantityPackage 00591-5590-01. 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)
Tranylcypromine sulfate tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine sulfate 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 sulfate 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 sulfat…
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 |
|---|---|---|---|---|
| Parnatetranylcypromine sulfate | Tranylcypromine sulfate 10 mg/1 | Tablet, Film coatedOral | Advanz Pharma (US) Corp. | 59212-447 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.