NDC codes

FDA NDC Directory
Product NDC (as listed)59212-447Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59212-0447Add 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
59212-447-105921204471059212044710100 TABLET, FILM COATED in 1 BOTTLE (59212-447-10)Marketed from Jan 14, 2013

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)
Parnate
Generic name (nonproprietary)
tranylcypromine sulfate
Active ingredients
Tranylcypromine sulfate — 10 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Advanz Pharma (US) Corp.NDC labeler code 59212
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 012342
Marketing start
Listing expires
Other FDA classes
Monoamine Oxidase Inhibitors (Mechanism)
Identifiers
Product ID 59212-447_1e311326-d555-4a01-91a5-f53077a450c4SPL ID 1e311326-d555-4a01-91a5-f53077a450c4SPL set ID b72d8187-dfcc-4ea0-b5e9-c0be95b69a27RxCUI 104838, 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

N459212044710 followed by a unit qualifier and the quantity

Package 59212-0447-10. 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)

PARNATE is indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. PARNATE 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) ] . PARNATE 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) PARNATE is not indicated for the initial treatment of MDD due to the potential for serious adve…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59212-447

What is NDC 59212-447?
59212-447 is the product NDC for Parnate (tranylcypromine sulfate), Tranylcypromine sulfate 10 mg/1 tablet, film coated, listed with the FDA by Advanz Pharma (US) Corp.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Parnate (Tranylcypromine sulfate).
What is the active ingredient?
Tranylcypromine sulfate.
Who is the labeler?
Advanz Pharma (US) Corp., NDC labeler code 59212. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Parnate?
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 012342

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

FDA NDC Directory listings under NDA 012342
ProductStrengthForm · routeLabelerProduct NDC
Tranylcypromine SulfateTranylcypromine sulfate 10 mg/1Tablet, Film coatedOralActavis Pharma, Inc.0591-5590

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