Prescription drug · NDA AUTHORIZED GENERIC
phenelzine sulfate NDC 59762-0119
Phenelzine sulfate 15 mg/1 · Tablet, Film coated · Oral · Mylan Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59762-0119-1 | 59762011901 | 60 TABLET, FILM COATED in 1 BOTTLE (59762-0119-1)Marketed from Mar 23, 2011 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- phenelzine sulfate
- Generic name (nonproprietary)
- phenelzine sulfate
- Active ingredients
- Phenelzine sulfate — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Mylan Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 011909
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 59762-0119_d7302106-710a-49a4-9ab4-2de28937306cSPL ID d7302106-710a-49a4-9ab4-2de28937306cSPL set ID fa041652-fdde-4794-a8d2-279dd309e075RxCUI 312347UNII 2681D7P965UPC 0359762011916
- 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
N459762011901followed by a unit qualifier and the quantityPackage 59762-0119-01. 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 Phenelzine sulfate has been found to be effective in depressed patients clinically characterized as "atypical," "nonendogenous," or "neurotic." These patients often have mixed anxiety and depression and phobic or hypochondriacal features. There is less conclusive evidence of its usefulness with severely depressed patients with endogenous features. Phenelzine sulfate should rarely be the first antidepressant drug used. Rather, it is more suitable for use with patients who have failed to respond to the drugs more commonly used for these conditions.
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 011909
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 |
|---|---|---|---|---|
| Nardilphenelzine sulfate | Phenelzine sulfate 15 mg/1 | Tablet, Film coatedOral | Parke-Davis Div of Pfizer Inc | 0071-0350 |