What is NDC 43353-378?

43353-378 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 43353-378 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-378Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0378Add 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
43353-378-15	43353037815	15 TABLET, FILM COATED in 1 BOTTLE (43353-378-15)Marketed from Aug 10, 2018
43353-378-30	43353037830	30 TABLET, FILM COATED in 1 BOTTLE (43353-378-30)Marketed from Aug 10, 2018
43353-378-45	43353037845	45 TABLET, FILM COATED in 1 BOTTLE (43353-378-45)Marketed from Aug 10, 2018
43353-378-60	43353037860	90 TABLET, FILM COATED in 1 BOTTLE (43353-378-60)Marketed from Jun 28, 2024

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
Marketing start: Aug 22, 2007
Listing expires: Dec 31, 2026
Identifiers: Product ID 43353-378_1bf61730-9fb6-49cb-e063-6394a90a3b21SPL ID 1bf61730-9fb6-49cb-e063-6394a90a3b21SPL set ID ac976282-fb68-4db0-912a-28f075b0716cRxCUI 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

N443353037815 followed by a unit qualifier and the quantity

Package 43353-0378-15. 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 28, 2024. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Mirtazapine tablets are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: dep…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-378

What is NDC 43353-378?: 43353-378 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, 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?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. 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 077666

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

FDA NDC Directory listings under ANDA 077666
Product	Strength	Form · route	Labeler	Product NDC
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Direct_Rx	61919-153
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Major Pharmaceuticals	0904-6519
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	McKesson Corporation dba SKY Packaging	63739-098
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	McKesson Corporation dba SKY Packaging	63739-099
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	A-S Medication Solutions	50090-1058
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-471
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-1590
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-554
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-717
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-0248
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-0247
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-0249
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-7297
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Proficient Rx LP	63187-206
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	AvKARE	42291-952