NDC codes

FDA NDC Directory
Product NDC (as listed)70518-1838Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-1838Add 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
70518-1838-0705181838007051818380030 TABLET, FILM COATED in 1 BLISTER PACK (70518-1838-0)Marketed from Jan 30, 2019

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
REMEDYREPACK INC.NDC labeler code 70518
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 076921
Marketing start
Listing expires
Identifiers
Product ID 70518-1838_497738f0-9d95-b22e-e063-6394a90a5d89SPL ID 497738f0-9d95-b22e-e063-6394a90a5d89SPL set ID 81d9e47e-ae81-4755-a5ee-546a038fadb4RxCUI 311725UNII 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

N470518183800 followed by a unit qualifier and the quantity

Package 70518-1838-00. 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 70518-1838

What is NDC 70518-1838?
70518-1838 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK 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?
REMEDYREPACK INC., NDC labeler code 70518. 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 coatedOralANI Pharmaceuticals, Inc.70954-83070954-0830-10
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralNCS HealthCare of KY, LLC dba Vangard Labs0615-866300615-8663-0500615-8663-39
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-048467046-0484-03
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-006867046-0068-03
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralSafecor Health LLC48433-07648433-0076-20
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralSafecor Health LLC48433-07748433-0077-20

All 139 Mirtazapine NDCs

Other NDCs under ANDA 076921

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

FDA NDC Directory listings under ANDA 076921
ProductStrengthForm · routeLabelerProduct NDC
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0664
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralNuCare Pharmaceuticals,Inc.68071-2784
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2819
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8459
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralUnit Dose Solutions, Inc.87441-058
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralNCS HealthCare of KY, Inc dba Vangard Labs0615-8268
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralBryant Ranch Prepack63629-3346
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralNCS HealthCare of KY, Inc dba Vangard Labs0615-8269
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2140
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-3038
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-119
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralCoupler LLC67046-0319
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-120
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralAmerican Health Packaging68084-121
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-1332
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralATLANTIC BIOLOGICALS CORP.17856-0101
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralAmerican Health Packaging60687-584
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7251
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralCoupler LLC67046-0484
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7324

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