NDC codes

FDA NDC Directory
Product NDC (as listed)0071-0350Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00071-0350Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0071-0350-60000710350600007103506060 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
Labeler
Parke-Davis Div of Pfizer IncNDC labeler code 0071
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

N400071035060 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0071-0350

What is NDC 0071-0350?
0071-0350 is the product NDC for Nardil (phenelzine sulfate), Phenelzine sulfate 15 mg/1 tablet, film coated, listed with the FDA by Parke-Davis Div of Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Nardil (Phenelzine Sulfate).
What is the active ingredient?
Phenelzine sulfate.
Who is the labeler?
Parke-Davis Div of Pfizer Inc, NDC labeler code 0071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nardil?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 011909

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 011909
ProductStrengthForm · routeLabelerProduct NDC
phenelzine sulfatePhenelzine sulfate 15 mg/1Tablet, Film coatedOralMylan Pharmaceuticals Inc.59762-0119

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