What is NDC 72189-626?

72189-626 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. It has 1 package NDC, shown above in 10- and 11-digit form.

Direct_Rx, NDC labeler code 72189. 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 72189-626 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-626Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0626Add 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
72189-626-30	72189062630	30 TABLET, FILM COATED in 1 BOTTLE (72189-626-30)Marketed from Jun 2, 2025

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 — 30 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Direct_RxNDC labeler code 72189
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
Marketing start: Jun 2, 2025
Listing expires: Dec 31, 2026
Identifiers: Product ID 72189-626_3699b988-6d9b-dcc1-e063-6394a90ab38dSPL ID 3699b988-6d9b-dcc1-e063-6394a90ab38dSPL set ID 3699b988-6d9a-dcc1-e063-6394a90ab38dRxCUI 314111UNII 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

N472189062630 followed by a unit qualifier and the quantity

Package 72189-0626-30. 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 2, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

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

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-626

What is NDC 72189-626?: 72189-626 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Direct_Rx. 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?: Direct_Rx, NDC labeler code 72189. 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 45 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-078	48433-0078-20

All 139 Mirtazapine NDCs

Other NDCs under ANDA 076921

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

FDA NDC Directory listings under ANDA 076921
Product	Strength	Form · route	Labeler	Product NDC
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, Inc dba Vangard Labs	0615-8269
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Proficient Rx LP	71205-481
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2581
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	NorthStar Rx LLC	72603-558
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, Inc dba Vangard Labs	0615-8268
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	ATLANTIC BIOLOGICALS CORP.	17856-0101
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2558
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	Redpharm Drug	67296-2302
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-3038
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2635
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-4989
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-0180
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-2819
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-2800
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	NuCare Pharmaceuticals,Inc.	68071-2784
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Bryant Ranch Prepack	71335-1332
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-1838
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8489
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Preferred Pharmaceuticals Inc.	68788-8459
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	American Health Packaging	68084-121

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