NDC codes

FDA NDC Directory
Product NDC (as listed)65862-032Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0032Add 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
65862-032-016586200320165862003201100 TABLET, FILM COATED in 1 BOTTLE (65862-032-01)Marketed from Oct 22, 2004
65862-032-056586200320565862003205500 TABLET, FILM COATED in 1 BOTTLE (65862-032-05)Marketed from Oct 22, 2004
65862-032-30658620032306586200323030 TABLET, FILM COATED in 1 BOTTLE (65862-032-30)Marketed from Oct 22, 2004
65862-032-32658620032326586200323230 TABLET, FILM COATED in 1 BLISTER PACK (65862-032-32)Marketed from Oct 22, 2004
65862-032-60658620032606586200326060 TABLET, FILM COATED in 1 BOTTLE (65862-032-60)Marketed from Oct 22, 2004
65862-032-90658620032906586200329090 TABLET, FILM COATED in 1 BOTTLE (65862-032-90)Marketed from Oct 22, 2004

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 — 45 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
Marketing start
Listing expires
Identifiers
Product ID 65862-032_e26778b1-5226-4107-9d12-3e8b7038bcccSPL ID e26778b1-5226-4107-9d12-3e8b7038bcccSPL set ID a4c012f0-50b6-42fb-9f06-a14632f23f2eRxCUI 311725, 311726, 314111, 476809UNII A051Q2099QUPC 0365862003010, 0365862031013, 0365862001016

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

N465862003201 followed by a unit qualifier and the quantity

Package 65862-0032-01. 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)

About NDC 65862-032

What is NDC 65862-032?
65862-032 is the product NDC for Mirtazapine, Mirtazapine 45 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 6 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?
Aurobindo Pharma Limited, NDC labeler code 65862. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCoupler LLC67046-031967046-0319-03
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-028055154-0280-00
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralCoupler LLC67046-062567046-0625-03
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralCoupler LLC67046-202467046-2024-03
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-866300615-8663-0500615-8663-39
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralANI Pharmaceuticals, Inc.70954-83070954-0830-10
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-048467046-0484-03
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-006867046-0068-03
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralSafecor Health LLC48433-07748433-0077-20
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralSafecor Health LLC48433-07648433-0076-20

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
ProductStrengthForm · routeLabelerProduct NDC
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-115
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2581
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2800
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2562
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralRedpharm Drug67296-2302
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralProficient Rx LP71205-481
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2635
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-001
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0664
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-003
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-0180
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-031
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-4989
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-032
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2819
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2784
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8459
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1838
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3346
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralNorthStar Rx LLC72603-558

Showing 20 of 39.

Free account

Log in to keep searching

You’ve used your 3 free searches. Med-Code is free: log in or create a free profile to keep looking up NDCs, J-codes and drugs.

Create a free profileLog in