Prescription drug · ANDA

Mirtazapine NDC 50090-1058

Mirtazapine 30 mg/1 · Tablet, Film coated · Oral · A-S Medication Solutions

NDC codes

FDA NDC Directory
Product NDC (as listed)50090-1058Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50090-1058Add 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
50090-1058-05009010580030 TABLET, FILM COATED in 1 BOTTLE (50090-1058-0)Marketed from Nov 28, 2014
50090-1058-25009010580260 TABLET, FILM COATED in 1 BOTTLE (50090-1058-2)Marketed from Nov 28, 2014
50090-1058-35009010580390 TABLET, FILM COATED in 1 BOTTLE (50090-1058-3)Marketed from Nov 28, 2014

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 — 30 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
A-S Medication SolutionsNDC labeler code 50090
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 077666
Marketing start
Listing expires
Identifiers
Product ID 50090-1058_eb2f9480-9478-4e6e-99c7-f48bfe8b0beeSPL ID eb2f9480-9478-4e6e-99c7-f48bfe8b0beeSPL set ID 44779383-3ddb-41df-8766-da5d7bef385eRxCUI 311725, 314111UNII 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

N450090105800 followed by a unit qualifier and the quantity

Package 50090-1058-00. 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 50090-1058

What is NDC 50090-1058?
50090-1058 is the product NDC for Mirtazapine, Mirtazapine 30 mg/1 tablet, film coated, listed with the FDA by A-S Medication Solutions. 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?
A-S Medication Solutions, NDC labeler code 50090. 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 coatedOralCardinal Health 107, LLC55154-7297
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralApotex Corp.60505-0247
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralApotex Corp.60505-0249
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralApotex Corp.60505-0248
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 coatedOralProficient Rx LP63187-206
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAvKARE42291-952
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralMajor Pharmaceuticals0904-6519
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralDirect_Rx61919-153
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAphena Pharma Solutions - Tennessee, LLC43353-378
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralMcKesson Corporation dba SKY Packaging63739-099
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralMcKesson Corporation dba SKY Packaging63739-098
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCoupler LLC67046-1590
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralProficient Rx LP63187-471

Med-Code uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in