Prescription drug · ANDA

Mirtazapine NDC 63187-206

Mirtazapine 15 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP

NDC codes

FDA NDC Directory
Product NDC (as listed)63187-206Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0206Add 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
63187-206-306318702063030 TABLET, FILM COATED in 1 BOTTLE (63187-206-30)Marketed from Feb 2, 2015
63187-206-606318702066060 TABLET, FILM COATED in 1 BOTTLE (63187-206-60)Marketed from Feb 2, 2015
63187-206-906318702069090 TABLET, FILM COATED in 1 BOTTLE (63187-206-90)Marketed from Feb 2, 2015

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
Labeler
Proficient Rx LPNDC labeler code 63187
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
Marketing start
Listing expires
Identifiers
Product ID 63187-206_fb4bf3e5-f62b-489a-ba75-8e94513f29caSPL ID fb4bf3e5-f62b-489a-ba75-8e94513f29caSPL set ID 3b516a33-b164-4e4f-bc18-e9d1e591323aRxCUI 311725, 311726UNII A051Q2099QUPC 0363187206307, 0363187471309

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

N463187020630 followed by a unit qualifier and the quantity

Package 63187-0206-30. 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)

INDICATIONS AND USAGE Mirtazapine tablets, USP are indicated for the treatment of major depressive disorder. The efficacy of mirtazapine tablets, USP in the treatment of major depressive disorder was established in six week controlled trials of outpatients whose diagnoses corresponded most closely to the Diagnostic and Statistical Manual of Mental Disorders – 3rd edition (DSM-III) category of major depressive disorder (see CLINICAL PHARMACOLOGY ). A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 63187-206

What is NDC 63187-206?
63187-206 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 63187. 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 45 mg/1Tablet, Film coatedOralSafecor Health LLC48433-07848433-0078-20

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 30 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-378
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 coatedOralA-S Medication Solutions50090-1058
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCoupler LLC67046-1590
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralProficient Rx LP63187-471
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralApotex Corp.60505-0247
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralApotex Corp.60505-0248
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralApotex Corp.60505-0249
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralProficient Rx LP63187-554
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC71610-717
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCardinal Health 107, LLC55154-7297
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAvKARE42291-952
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6519

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