Prescription drug · ANDA
Tranylcypromine Sulfate NDC 64380-176
Tranylcypromine sulfate 10 mg/1 · Tablet, Film coated · Oral · Strides Pharma Science Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64380-176-01 | 64380017601 | 100 TABLET, FILM COATED in 1 BOTTLE (64380-176-01)Marketed from Apr 11, 2022 |
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 Sulfate
- Generic name (nonproprietary)
- tranylcypromine sulfate
- Active ingredients
- Tranylcypromine sulfate — 10 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040640
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 64380-176_8f68f947-b896-4164-87bf-1bddc7afb6b2SPL ID 8f68f947-b896-4164-87bf-1bddc7afb6b2SPL set ID 7974d4ad-c419-4c7f-bbd6-f631d53e30deRxCUI 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
N464380017601followed by a unit qualifier and the quantityPackage 64380-0176-01. 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 is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine Sulfate 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)] . Tranylcypromine Sulfate 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) Tranylcypromine Sulfate is not indicated for the in…
Excerpt only. Read the full label for complete information.