Prescription drug · NDA
Nardil (phenelzine sulfate) NDC 0071-0350
Phenelzine sulfate 15 mg/1 · Tablet, Film coated · Oral · Parke-Davis Div of Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0071-0350-60 | 00071035060 | 60 TABLET, FILM COATED in 1 BOTTLE (0071-0350-60)Marketed from Jun 9, 1961 |
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)
- Nardil
- Generic name (nonproprietary)
- phenelzine sulfate
- Active ingredients
- Phenelzine sulfate — 15 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 011909
- Marketing start
- Listing expires
- Other FDA classes
- Monoamine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 0071-0350_87512ea9-1c68-4ec1-a8d0-37776f006227SPL ID 87512ea9-1c68-4ec1-a8d0-37776f006227SPL set ID 513a41d0-37d4-4355-8a6d-a2c643bce6faRxCUI 104836, 312347UNII 2681D7P965UPC 0300710350601
- 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
N400071035060followed by a unit qualifier and the quantityPackage 00071-0350-60. 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 NARDIL 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. NARDIL 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 |
|---|---|---|---|---|
| phenelzine sulfate | Phenelzine sulfate 15 mg/1 | Tablet, Film coatedOral | Mylan Pharmaceuticals Inc. | 59762-0119 |