NDC 0052-0108

REMERONSOLTAB

Mirtazapine

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

• Product ID: 0052-0108_1594f744-89b7-488d-bf1b-516340e924f9
• NDC: 0052-0108
• Product Type: Human Prescription Drug
• Proprietary Name: REMERONSOLTAB
• Generic Name: Mirtazapine
• Dosage Form: Tablet, Orally Disintegrating
• Route of Administration: ORAL
• Marketing Start Date: 2001-01-12
• Marketing Category: NDA / NDA
• Application Number: NDA021208
• 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 0052-0108-30

5 BLISTER PACK in 1 BOX (0052-0108-30) > 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (0052-0108-06)

• Marketing Start Date: 2001-01-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0052-0108-06 [00052010806]

REMERONSOLTAB TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA021208
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-01-12

NDC 0052-0108-93 [00052010893]

REMERONSOLTAB TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA021208
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2001-01-12
• Marketing End Date: 2011-08-17

NDC 0052-0108-30 [00052010830]

REMERONSOLTAB TABLET, ORALLY DISINTEGRATING

• Marketing Category: NDA
• Application Number: NDA021208
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2001-01-12

Drug Details

Active Ingredients

Ingredient	Strength
MIRTAZAPINE	30 mg/1

OpenFDA Data

• SPL SET ID: 31f48378-27db-424f-a4c5-82584a553c35
• Manufacturer:
  • Organon USA Inc.
• UNII:
  • A051Q2099Q
• RxNorm Concept Unique ID - RxCUI:
  • 752871
  • 752870
  • 283407
  • 283406
  • 752869
  • 283485

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

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