NDC 70518-0903

REMERON

Mirtazapine

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

• Product ID: 70518-0903_604157f5-f843-4a01-e053-2991aa0a18bf
• NDC: 70518-0903
• Product Type: Human Prescription Drug
• Proprietary Name: REMERON
• Generic Name: Mirtazapine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-12-12
• Marketing Category: NDA / NDA
• Application Number: NDA020415
• Labeler Name: REMEDYREPACK INC.
• Substance Name: MIRTAZAPINE
• Active Ingredient Strength: 15 mg/1
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70518-0903-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0903-0)

• Marketing Start Date: 2017-12-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0903-0 [70518090300]

REMERON TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020415
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-12-12
• Marketing End Date: 2020-05-07

Drug Details

Active Ingredients

Ingredient	Strength
MIRTAZAPINE	15 mg/1

OpenFDA Data

• SPL SET ID: 9f28839b-5a69-4583-b55f-b9fb8a024c82
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • A051Q2099Q
• RxNorm Concept Unique ID - RxCUI:
  • 211322
  • 311725

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