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NDC 78206-0160-01 REMERON 15 mg/1 Details
REMERON 15 mg/1
REMERON is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Organon LLC. The primary component is MIRTAZAPINE.
MedlinePlus Drug Summary
Mirtazapine is used to treat depression. Mirtazapine is in a class of medications called antidepressants. It works by increasing certain types of activity in the brain to maintain mental balance.
Related Packages: 78206-0160-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Mirtazapine
Product Information
| NDC | 78206-0160 |
|---|---|
| Product ID | 78206-160_9ca37cbe-04af-433a-940a-326169418b9d |
| Associated GPIs | 58030050000315 |
| GCN Sequence Number | 046450 |
| GCN Sequence Number Description | mirtazapine TABLET 15 MG ORAL |
| HIC3 | H7B |
| HIC3 Description | ALPHA-2 RECEPTOR ANTAGONIST ANTIDEPRESSANTS |
| GCN | 16732 |
| HICL Sequence Number | 011505 |
| HICL Sequence Number Description | MIRTAZAPINE |
| Brand/Generic | Brand |
| Proprietary Name | REMERON |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MIRTAZAPINE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | mg/1 |
| Substance Name | MIRTAZAPINE |
| Labeler Name | Organon LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020415 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 78206-0160-01 (78206016001)
| NDC Package Code | 78206-160-01 |
|---|---|
| Billing NDC | 78206016001 |
| Package | 1 BOTTLE in 1 CARTON (78206-160-01) / 30 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2021-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |