NDC 0052-4365

REMERON

Mirtazapine

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

• Product ID: 0052-4365_1594f744-89b7-488d-bf1b-516340e924f9
• NDC: 0052-4365
• Product Type: Human Prescription Drug
• Proprietary Name: REMERON
• Generic Name: Mirtazapine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2018-05-17
• Marketing Category: NDA / NDA
• Application Number: NDA020415
• Labeler Name: Organon USA Inc.
• Substance Name: MIRTAZAPINE
• Active Ingredient Strength: 30 mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0052-4365-01

1 BOTTLE in 1 CARTON (0052-4365-01) > 30 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2018-05-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0052-4365-01 [00052436501]

REMERON TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020415
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-17

Drug Details

Active Ingredients

Ingredient	Strength
MIRTAZAPINE	30 mg/1

OpenFDA Data

• SPL SET ID: 010f9162-9f7f-4b6d-a6e4-4f832f26f38e
• Manufacturer:
  • Organon USA Inc.
• UNII:
  • A051Q2099Q
• RxNorm Concept Unique ID - RxCUI:
  • 261135
  • 311725
  • 311726
  • 211323
  • 211322
  • 314111

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

NDC	Brand Name	Generic Name
0052-0105	REMERON	MIRTAZAPINE
0052-0107	REMERON	MIRTAZAPINE
0052-0109	REMERON	MIRTAZAPINE
0052-4364	REMERON	MIRTAZAPINE
0052-4365	REMERON	MIRTAZAPINE
70518-0903	REMERON	REMERON
70518-2176	REMERON	REMERON
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
0052-0106	REMERONSOLTAB	MIRTAZAPINE
0052-0108	REMERONSOLTAB	MIRTAZAPINE
0052-0110	REMERONSOLTAB	MIRTAZAPINE