NDC codes

FDA NDC Directory
Product NDC (as listed)66993-606Labeler and product segments. Claims need a package NDC.
Product NDC at billing width66993-0606Add 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
66993-606-046699306060466993060604500 TABLET, FILM COATED in 1 BOTTLE (66993-606-04)Marketed from Jun 1, 2023
66993-606-30669930606306699306063030 TABLET, FILM COATED in 1 BOTTLE (66993-606-30)Marketed from Jun 1, 2023

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 — 7.5 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Prasco LaboratoriesNDC labeler code 66993
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 216751
Marketing start
Listing expires
Identifiers
Product ID 66993-606_e1a19354-1c97-49ed-8ec9-bb895dbe69f3SPL ID e1a19354-1c97-49ed-8ec9-bb895dbe69f3SPL set ID 8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4RxCUI 311725, 311726, 314111, 476809UNII A051Q2099QUPC 0366993607306, 0366993607047, 0366993608044

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

N466993060604 followed by a unit qualifier and the quantity

Package 66993-0606-04. 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 66993-606

What is NDC 66993-606?
66993-606 is the product NDC for Mirtazapine, Mirtazapine 7.5 mg/1 tablet, film coated, listed with the FDA by Prasco Laboratories. It has 2 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?
Prasco Laboratories, NDC labeler code 66993. 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 216751

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

FDA NDC Directory listings under ANDA 216751
ProductStrengthForm · routeLabelerProduct NDC
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralPrasco Laboratories66993-607
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralPrasco Laboratories66993-608
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralPrasco Laboratories66993-609
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-846
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-853

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