What is NDC 71335-0286?

71335-0286 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mirtazapine NDC 71335-0286 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-0286Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-0286Add 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 NDC	11-digit (billing)	Package
71335-0286-1	7133502860171335028601	30 TABLET in 1 BOTTLE (71335-0286-1)Marketed from Sep 9, 2021
71335-0286-2	7133502860271335028602	60 TABLET in 1 BOTTLE (71335-0286-2)Marketed from Nov 8, 2021
71335-0286-3	7133502860371335028603	90 TABLET in 1 BOTTLE (71335-0286-3)Marketed from Dec 27, 2021
71335-0286-4	7133502860471335028604	120 TABLET in 1 BOTTLE (71335-0286-4)Marketed from Dec 27, 2021
71335-0286-5	7133502860571335028605	15 TABLET in 1 BOTTLE (71335-0286-5)Marketed from Dec 27, 2021
71335-0286-6	7133502860671335028606	180 TABLET in 1 BOTTLE (71335-0286-6)Marketed from Dec 27, 2021
71335-0286-7	7133502860771335028607	45 TABLET in 1 BOTTLE (71335-0286-7)Marketed from Dec 27, 2021
71335-0286-8	7133502860871335028608	21 TABLET in 1 BOTTLE (71335-0286-8)Marketed from Dec 27, 2021

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
Route: Oral
Labeler: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 076541
Marketing start: Apr 22, 2004
Listing expires: Dec 31, 2026
Identifiers: Product ID 71335-0286_7bcab2eb-126f-4e34-949a-a7002e06ed12SPL ID 7bcab2eb-126f-4e34-949a-a7002e06ed12SPL set ID 9f0f52e8-3318-4da2-b0d9-ea3d33bfe41eRxCUI 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

N471335028601 followed by a unit qualifier and the quantity

Package 71335-0286-01. 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 Oct 26, 2023. 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 71335-0286

What is NDC 71335-0286?: 71335-0286 is the product NDC for Mirtazapine, Mirtazapine 15 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 8 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0319	67046-0319-03
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Cardinal Health 107, LLC	55154-0280	55154-0280-00
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0625	67046-0625-03
Mirtazapine	Mirtazapine 45 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-2024	67046-2024-03
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8663	00615-8663-0500615-8663-39
Mirtazapine	Mirtazapine 7.5 mg/1	Tablet, Film coatedOral	ANI Pharmaceuticals, Inc.	70954-830	70954-0830-10
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0484	67046-0484-03
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Coupler LLC	67046-0068	67046-0068-03
Mirtazapine	Mirtazapine 30 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-077	48433-0077-20
Mirtazapine	Mirtazapine 15 mg/1	Tablet, Film coatedOral	Safecor Health LLC	48433-076	48433-0076-20

All 139 Mirtazapine NDCs

Other NDCs under ANDA 076541

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

FDA NDC Directory listings under ANDA 076541
Product	Strength	Form · route	Labeler	Product NDC
Mirtazapine	Mirtazapine 7.5 mg/1	TabletOral	AvKARE	42291-494
Mirtazapine	Mirtazapine 15 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-499
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-500
Mirtazapine	Mirtazapine 45 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-501
Mirtazapine	Mirtazapine 7.5 mg/1	TabletOral	Sun Pharmaceutical Industries, Inc.	57664-510
Mirtazapine	Mirtazapine 15 mg/1	TabletOral	Bryant Ranch Prepack	63629-2366
Mirtazapine	Mirtazapine 15 mg/1	TabletOral	Bryant Ranch Prepack	63629-2367
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	Bryant Ranch Prepack	63629-2368
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	REMEDYREPACK INC.	70518-4548
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-0441
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	Bryant Ranch Prepack	71335-2963
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-713
Mirtazapine	Mirtazapine 15 mg/1	TabletOral	Bryant Ranch Prepack	72162-1639
Mirtazapine	Mirtazapine 30 mg/1	TabletOral	Bryant Ranch Prepack	72162-1640