What is NDC 0378-3530?

0378-3530 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.

Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 0378-3530 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3530Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3530Add 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
0378-3530-01	0037835300100378353001	100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-01)Marketed from Aug 2, 2016
0378-3530-05	0037835300500378353005	500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-05)Marketed from Jun 20, 2003
0378-3530-93	0037835309300378353093	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-3530-93)Marketed from Jun 20, 2003

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Mylan Pharmaceuticals Inc.NDC labeler code 0378
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076122
Marketing start: Jun 20, 2003
Listing expires: Dec 31, 2027
Identifiers: Product ID 0378-3530_681d9ec4-046b-4c0e-b85f-2468620c724bSPL ID 681d9ec4-046b-4c0e-b85f-2468620c724bSPL set ID 711aa80b-8fc6-49e6-9494-3db31d9b53a4RxCUI 311725, 311726, 314111UNII A051Q2099QUPC 0303783545936, 0303783530932

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

N400378353001 followed by a unit qualifier and the quantity

Package 00378-3530-01. 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 Oct 4, 2022. 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) ] . Mirtazapine 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 0378-3530

What is NDC 0378-3530?: 0378-3530 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by Mylan Pharmaceuticals Inc.. It has 3 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?: Mylan Pharmaceuticals Inc., NDC labeler code 0378. 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 076122

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

FDA NDC Directory listings under ANDA 076122
Product	Strength	Form · route	Labeler	Product NDC
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-475
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-3515
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Aphena Pharma Solutions - Tennessee, LLC	71610-523
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Mylan Pharmaceuticals Inc.	0378-3545
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-076
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	REMEDYREPACK INC.	70518-4322
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-077
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-078
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-352
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-350
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0280
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Golden State Medical Supply, Inc.	51407-351
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-5355
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-087
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-086
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Mylan Institutional Inc.	51079-088