Prescription drug · ANDA

Mirtazapine NDC 70518-2819

Mirtazapine 7.5 mg/1 · Tablet, Film coated · Oral · REMEDYREPACK INC.

NDC codes

FDA NDC Directory
Product NDC (as listed)70518-2819Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-2819Add 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
70518-2819-27051828190230 TABLET, FILM COATED in 1 BLISTER PACK (70518-2819-2)Marketed from Jul 12, 2023

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 — 7.5 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 70518-2819_57c265aa-acef-47d8-e063-6394a90a2384SPL ID 57c265aa-acef-47d8-e063-6394a90a2384SPL set ID 10ea9d83-19c3-4f3b-a1cc-cfc48b42507fRxCUI 476809UNII 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

N470518281902 followed by a unit qualifier and the quantity

Package 70518-2819-02. 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 70518-2819

What is NDC 70518-2819?
70518-2819 is the product NDC for Mirtazapine, Mirtazapine 7.5 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 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 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 45 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-032
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2453
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1309
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0305
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralProficient Rx LP63187-403
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralCoupler LLC67046-0625
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-003
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-001
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-007
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1397
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralBryant Ranch Prepack72162-2562
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-2140
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-010
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-008
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralAurolife Pharma LLC13107-031
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.57237-009
MirtazapineMirtazapine 30 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-003
MirtazapineMirtazapine 7.5 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-001
MirtazapineMirtazapine 45 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-2581
MirtazapineMirtazapine 15 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0664

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