NDC 68788-7196

Mirtazapine

Mirtazapine

Mirtazapine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Mirtazapine.

• Product ID: 68788-7196_5ffa6ac3-4e87-4392-ac57-a55cb67743ee
• NDC: 68788-7196
• Product Type: Human Prescription Drug
• Proprietary Name: Mirtazapine
• Generic Name: Mirtazapine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-18
• Marketing Category: ANDA / ANDA
• Application Number: ANDA077666
• Labeler Name: Preferred Pharmaceuticals Inc.
• Substance Name: MIRTAZAPINE
• Active Ingredient Strength: 30 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 68788-7196-6

60 TABLET, FILM COATED in 1 BOTTLE (68788-7196-6)

• Marketing Start Date: 2018-07-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68788-7196-1 [68788719601]

Mirtazapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077666
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-18

NDC 68788-7196-6 [68788719606]

Mirtazapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077666
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-18

NDC 68788-7196-9 [68788719609]

Mirtazapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077666
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-18

NDC 68788-7196-3 [68788719603]

Mirtazapine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA077666
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-07-18

Drug Details

Active Ingredients

Ingredient	Strength
MIRTAZAPINE	30 mg/1

OpenFDA Data

• SPL SET ID: 630c4ca4-f8b7-417e-9fb3-1e8bd778de24
• Manufacturer:
  • Preferred Pharmaceuticals Inc.
• UNII:
  • A051Q2099Q
• RxNorm Concept Unique ID - RxCUI:
  • 314111

NDC Crossover Matching brand name "Mirtazapine" or generic name "Mirtazapine"

NDC	Brand Name	Generic Name
0093-7206	Mirtazapine	Mirtazapine
0093-7207	Mirtazapine	Mirtazapine
0093-7208	Mirtazapine	Mirtazapine
0115-1653	Mirtazapine	Mirtazapine
0115-1654	Mirtazapine	Mirtazapine
0115-1656	Mirtazapine	Mirtazapine
0185-0020	mirtazapine	mirtazapine
68071-1716	Mirtazapine	Mirtazapine
68071-1659	Mirtazapine	Mirtazapine
68071-4045	Mirtazapine	Mirtazapine
68071-4003	Mirtazapine	Mirtazapine
68071-4295	Mirtazapine	Mirtazapine
68071-4239	Mirtazapine	Mirtazapine
68071-4379	Mirtazapine	Mirtazapine
68071-4752	Mirtazapine	Mirtazapine
68071-4539	Mirtazapine	Mirtazapine
68084-121	Mirtazapine	Mirtazapine
68084-120	Mirtazapine	Mirtazapine
68084-119	Mirtazapine	Mirtazapine
68382-679	mirtazapine	mirtazapine
68382-676	mirtazapine	mirtazapine
68382-677	mirtazapine	mirtazapine
68788-7196	Mirtazapine	Mirtazapine
68788-7172	Mirtazapine	Mirtazapine
68788-7251	Mirtazapine	Mirtazapine
68788-9981	Mirtazapine	Mirtazapine
0591-1117	Mirtazapine	Mirtazapine
0591-1118	Mirtazapine	Mirtazapine
70518-0101	Mirtazapine	Mirtazapine
70518-0180	Mirtazapine	Mirtazapine
0591-1119	Mirtazapine	Mirtazapine
0591-2470	Mirtazapine	Mirtazapine
70518-0316	Mirtazapine	Mirtazapine
70518-0102	Mirtazapine	Mirtazapine
70518-0276	Mirtazapine	Mirtazapine
70518-0901	Mirtazapine	Mirtazapine
70518-0977	Mirtazapine	Mirtazapine
70518-1397	Mirtazapine	Mirtazapine
70518-1352	Mirtazapine	Mirtazapine
70518-1309	Mirtazapine	Mirtazapine
70518-1293	Mirtazapine	Mirtazapine
70518-1838	Mirtazapine	Mirtazapine
70518-1583	Mirtazapine	Mirtazapine
70771-1072	mirtazapine	mirtazapine
70771-1073	mirtazapine	mirtazapine
70771-1074	mirtazapine	mirtazapine
71335-0441	Mirtazapine	Mirtazapine
71335-0286	Mirtazapine	Mirtazapine
71335-0372	Mirtazapine	Mirtazapine
71335-0717	Mirtazapine	Mirtazapine