Tranylcypromine NDC 43547-655

NDC codes

FDA NDC Directory

Product NDC (as listed)43547-655Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43547-0655Add 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
43547-655-10	43547065510	100 TABLET in 1 BOTTLE (43547-655-10)Marketed from Dec 10, 2022

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): Tranylcypromine
Generic name (nonproprietary): tranylcypromine
Active ingredients: Tranylcypromine sulfate — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Solco Healthcare US, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213503
Marketing start: Dec 10, 2022
Listing expires: Dec 31, 2026
Other FDA classes: Monoamine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 43547-655_df2e24b3-c948-4f36-863c-589296f651fbSPL ID df2e24b3-c948-4f36-863c-589296f651fbSPL set ID 3c14a558-2df4-4d93-97dd-640dec6ee785RxCUI 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

N443547065510 followed by a unit qualifier and the quantity

Package 43547-0655-10. 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 Dec 20, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

Tranylcypromine tablets are indicated for the treatment of major depressive disorder (MDD) in adult patients who have not responded adequately to other antidepressants. Tranylcypromine tablets are 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) ] . • Tranylcypromine tablets are 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 ) • Tranylcypromine tablets are not indicat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 213503

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

FDA NDC Directory listings under ANDA 213503
Product	Strength	Form · route	Labeler	Product NDC
Tranylcypromine	Tranylcypromine sulfate 10 mg/1	TabletOral	REMEDYREPACK INC.	70518-4708