NDC codes

FDA NDC Directory
Product NDC (as listed)57237-013Labeler and product segments. Claims need a package NDC.
Product NDC at billing width57237-0013Add 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
57237-013-06572370013065 BLISTER PACK in 1 CARTON (57237-013-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 28, 2006

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, Orally disintegrating
Route
Oral
Labeler
Rising Pharma Holdings, Inc.NDC labeler code 57237
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077376
Marketing start
Listing expires
Identifiers
Product ID 57237-013_ed2cd1df-697f-4e63-8097-7802be5eb6bbSPL ID ed2cd1df-697f-4e63-8097-7802be5eb6bbSPL set ID 73b7bbd9-7dba-4559-890f-3f8dd821e215RxCUI 283406, 283407, 283485UNII 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

N457237001306 followed by a unit qualifier and the quantity

Package 57237-0013-06. 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 orally disintegrating tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14) ]. Mirtazapine orally disintegrating 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 57237-013

What is NDC 57237-013?
57237-013 is the product NDC for Mirtazapine, Mirtazapine 45 mg/1 tablet, orally disintegrating, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, 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?
Rising Pharma Holdings, Inc., NDC labeler code 57237. 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 077376

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

FDA NDC Directory listings under ANDA 077376
ProductStrengthForm · routeLabelerProduct NDC
MirtazapineMirtazapine 15 mg/1Tablet, Orally disintegratingOralCardinal Health 107, LLC55154-8335
MirtazapineMirtazapine 15 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-011
MirtazapineMirtazapine 30 mg/1Tablet, Orally disintegratingOralRising Pharma Holdings, Inc.57237-012
MirtazapineMirtazapine 15 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-021
MirtazapineMirtazapine 30 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-022
MirtazapineMirtazapine 45 mg/1Tablet, Orally disintegratingOralAurobindo Pharma Limited65862-023
MirtazapineMirtazapine 30 mg/1Tablet, Orally disintegratingOralBryant Ranch Prepack71335-2978

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