What is NDC 72578-103?

72578-103 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, orally disintegrating, listed with the FDA by Viona Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Viona Pharmaceuticals Inc., NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mirtazapine?

138 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mirtazapine NDC 72578-103 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72578-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72578-0103Add 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
72578-103-84	7257801038472578010384	5 BLISTER PACK in 1 CARTON (72578-103-84) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-103-69)Marketed from Aug 7, 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): Mirtazapine
Generic name (nonproprietary): mirtazapine
Active ingredients: Mirtazapine — 15 mg/1
Dosage form: Tablet, Orally disintegrating
Route: Oral
Labeler: Viona Pharmaceuticals Inc.NDC labeler code 72578
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205798
Marketing start: Aug 7, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 72578-103_9ad8f423-a877-4069-8a11-92e1f934974aSPL ID 9ad8f423-a877-4069-8a11-92e1f934974aSPL set ID ed491abe-9412-428b-8e24-57242862c99aRxCUI 283406, 283407, 283485UNII A051Q2099Q

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

N472578010384 followed by a unit qualifier and the quantity

Package 72578-0103-84. 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 Jun 24, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ] . Mirtazapine orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72578-103

What is NDC 72578-103?: 72578-103 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, orally disintegrating, listed with the FDA by Viona Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mirtazapine.
What is the active ingredient?: Mirtazapine.
Who is the labeler?: Viona Pharmaceuticals Inc., NDC labeler code 72578. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mirtazapine?: 138 other product NDCs are listed under this name. See all Mirtazapine 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 Mirtazapine NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0319	67046-0319-03
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0280	55154-0280-00
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0625	67046-0625-03
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-2024	67046-2024-03
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8663	00615-8663-0500615-8663-39
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-830	70954-0830-10
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0484	67046-0484-03
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0068	67046-0068-03
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-077	48433-0077-20
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-076	48433-0076-20

All 139 Mirtazapine NDCs

Other NDCs under ANDA 205798

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

FDA NDC Directory listings under ANDA 205798
Product	Strength	Form · route	Labeler	Product NDC
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Orally disintegratingOral	Bryant Ranch Prepack	71335-2471
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Orally disintegratingOral	Viona Pharmaceuticals Inc.	72578-104
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Orally disintegratingOral	Viona Pharmaceuticals Inc.	72578-105
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Orally disintegratingOral	SQUARE PHARMACEUTICALS LIMITED	76483-110
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Orally disintegratingOral	SQUARE PHARMACEUTICALS LIMITED	76483-111
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Orally disintegratingOral	SQUARE PHARMACEUTICALS LIMITED	76483-112