NDC codes

FDA NDC Directory
Product NDC (as listed)60505-0247Labeler and product segments. Claims need a package NDC.
Product NDC at billing width60505-0247Add 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
60505-0247-16050502470130 TABLET, FILM COATED in 1 BOTTLE (60505-0247-1)Marketed from Aug 22, 2007
60505-0247-360505024703100 TABLET, FILM COATED in 1 BOTTLE (60505-0247-3)Marketed from Aug 22, 2007
60505-0247-560505024705500 TABLET, FILM COATED in 1 BOTTLE (60505-0247-5)Marketed from Aug 22, 2007
60505-0247-8605050247081000 TABLET, FILM COATED in 1 BOTTLE (60505-0247-8)Marketed from Aug 22, 2007

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
Labeler
Apotex Corp.NDC labeler code 60505
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
Marketing start
Listing expires
Identifiers
Product ID 60505-0247_cf56cd8c-e0aa-ae8b-38fe-396561abe6bfSPL ID cf56cd8c-e0aa-ae8b-38fe-396561abe6bf

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

N460505024701 followed by a unit qualifier and the quantity

Package 60505-0247-01. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 60505-0247

What is NDC 60505-0247?
60505-0247 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, film coated, listed with the FDA by Apotex Corp.. 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?
Apotex Corp., NDC labeler code 60505. 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 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
ProductStrengthForm · routeLabelerProduct NDC
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralDirect_Rx61919-153
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6519
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralMcKesson Corporation dba SKY Packaging63739-098
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralMcKesson Corporation dba SKY Packaging63739-099
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-378
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-1058
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralProficient Rx LP63187-471
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCoupler LLC67046-1590
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralProficient Rx LP63187-554
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-717
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralApotex Corp.60505-0248
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralApotex Corp.60505-0249
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7297
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralProficient Rx LP63187-206
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAvKARE42291-952

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