Prescription drug · ANDA

Mirtazapine NDC 13107-031

Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · Aurolife Pharma LLC

NDC codes

FDA NDC Directory
Product NDC (as listed)13107-031Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13107-0031Add 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 NDC11-digit (billing)PackageCopy
13107-031-0113107003101100 TABLET, FILM COATED in 1 BOTTLE (13107-031-01)Marketed from Aug 17, 2009
13107-031-0513107003105500 TABLET, FILM COATED in 1 BOTTLE (13107-031-05)Marketed from Aug 17, 2009
13107-031-301310700313030 TABLET, FILM COATED in 1 BOTTLE (13107-031-30)Marketed from Aug 17, 2009
13107-031-321310700313230 TABLET, FILM COATED in 1 BLISTER PACK (13107-031-32)Marketed from Aug 17, 2009
13107-031-341310700313430 TABLET, FILM COATED in 1 BOTTLE (13107-031-34)Marketed from Aug 17, 2009
13107-031-601310700316060 TABLET, FILM COATED in 1 BOTTLE (13107-031-60)Marketed from Aug 17, 2009
13107-031-901310700319090 TABLET, FILM COATED in 1 BOTTLE (13107-031-90)Marketed from Aug 17, 2009

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, Film coated
Route
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
Marketing start
Listing expires
Identifiers
Product ID 13107-031_4329eeed-8071-4b6c-887d-0cd00647b84cSPL ID 4329eeed-8071-4b6c-887d-0cd00647b84cSPL set ID aa05d606-29fd-443e-802b-1d65584d6bb1RxCUI 311725, 311726, 314111, 476809UNII 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

N413107003101 followed by a unit qualifier and the quantity

Package 13107-0031-01. 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 . 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)

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
ProductStrengthForm · routeLabelerProduct NDC
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralCoupler LLC67046-2024
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-119
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-120
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-121
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-0068
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3346
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0964
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCoupler LLC67046-0319
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-0484
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7251
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2412
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-584
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-100
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-001
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-003
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7324
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-115
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1055
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-058
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralNCS HealthCare of KY, Inc dba Vangard Labs0615-8268

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Mirtazapine NDC 13107-031 | Med-Code