REMERON
- Product NDC
- 0052-0107
- 11-digit product format
- 000520107
- Labeler code
- 0052
- Product ID
- 0052-0107_325197a6-1a5f-4c6f-bb05-c8b3f64ce3ad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MIRTAZAPINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Organon USA Inc.
- Application
- NDA020415
- Marketing category
- NDA
- Marketing start
- 1996-06-14
- Marketing end
- 0000-00-00
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2022-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| LACTOSE | INACTIVE INGREDIENT | J2B2A4N98G | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | REMERON (MIRTAZAPINE) TABLET, FILM COATED [PHYSICIANS TOTAL CARE, INC.] | 1 | |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0052-0107-30 | 00052010730 | 1 BOTTLE in 1 CARTON (0052-0107-30) > 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 1996-06-14 | 0000-00-00 | No | No | Current |