What is NDC 43386-360?

43386-360 is the product NDC for Phenelzine Sulfate, Phenelzine sulfate 15 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Phenelzine Sulfate?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Phenelzine Sulfate NDC 43386-360 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43386-360Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43386-0360Add 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 NDC	11-digit (billing)	Package	Copy
43386-360-21	4338603602143386036021	60 TABLET in 1 BOTTLE (43386-360-21)Marketed from Feb 14, 2011

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): Phenelzine Sulfate
Generic name (nonproprietary): phenelzine sulfate
Active ingredients: Phenelzine sulfate — 15 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Lupin Pharmaceuticals,Inc.NDC labeler code 43386
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200181
Marketing start: Dec 14, 2010
Listing expires: Dec 31, 2027
Other FDA classes: Monoamine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 43386-360_1eb0b695-ce65-45c2-914a-87bc2105b139SPL ID 1eb0b695-ce65-45c2-914a-87bc2105b139SPL set ID 40483372-448f-4284-976c-8462ef256661RxCUI 312347UNII 2681D7P965UPC 0343386360215
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

N443386036021 followed by a unit qualifier and the quantity

Package 43386-0360-21. 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 Sep 29, 2017. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Phenelzine Sulfate Tablets, USP 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 Tablets 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 43386-360

What is NDC 43386-360?: 43386-360 is the product NDC for Phenelzine Sulfate, Phenelzine sulfate 15 mg/1 tablet, listed with the FDA by Lupin Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Phenelzine Sulfate.
What is the active ingredient?: Phenelzine sulfate.
Who is the labeler?: Lupin Pharmaceuticals,Inc., NDC labeler code 43386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Phenelzine Sulfate?: 1 other product NDC are listed under this name. See all Phenelzine Sulfate NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Phenelzine Sulfate NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
phenelzine sulfate	Phenelzine sulfate 15 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	59762-0119	59762-0119-01