NDC 0052-0109
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 | 0052-0109_1e81ca29-d807-45e6-a669-e432efcfc339 |
| NDC | 0052-0109 |
| Product Type | Human Prescription Drug |
| Proprietary Name | REMERON |
| Generic Name | Mirtazapine |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 1997-03-11 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020415 |
| Labeler Name | Organon USA Inc. |
| Substance Name | MIRTAZAPINE |
| Active Ingredient Strength | 45 mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 0052-0109-30
1 BOTTLE in 1 CARTON (0052-0109-30) > 30 TABLET, FILM COATED in 1 BOTTLE
| Marketing Start Date | 1997-03-11 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0052-0109-30 [00052010930]
REMERON TABLET, FILM COATED
| Marketing Category | NDA |
| Application Number | NDA020415 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | EA |
| Marketing Start Date | 1997-03-11 |
| Marketing End Date | 2018-01-31 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| MIRTAZAPINE | 45 mg/1 |
OpenFDA Data
| SPL SET ID: | 010f9162-9f7f-4b6d-a6e4-4f832f26f38e |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
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 |
Trademark Results [REMERON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 REMERON 74552154 2061796 Live/Registered |
MERCK SHARP & DOHME B.V. 1994-07-21 |
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