Mirtazapine
- Product NDC
- 63187-554
- 11-digit product format
- 631870554
- Labeler code
- 63187
- Product ID
- 63187-554_98bb70ff-3255-40e9-907b-1ef725068c85
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA077666
- Marketing category
- ANDA
- Marketing start
- 2007-08-22
- Substance
- MIRTAZAPINE
- Active strength
- 30 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Mirtazapine
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MIRTAZAPINE | 30 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 314111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63187-554-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
| 63187-554-60 | Mirtazapine | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 3 |
| 63187-554-90 | Mirtazapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| Hydroxypropyl Cellulose (Type H) | INACTIVE INGREDIENT | RFW2ET671P | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63187-554 | MIRTAZAPINE TABLET, FILM COATED [PROFICIENT RX LP] | 3 | Current NDC, Legacy NDC, 3 package rows | 20220514_a2f01ffd-fd48-499b-9126-8eb9048a5722.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63187-554-30 | 63187055430 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-554-30) | 2015-09-01 | 0000-00-00 | No | No | Current |
| 63187-554-60 | 63187055460 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-554-60) | 2015-09-01 | 0000-00-00 | No | No | Current |
| 63187-554-90 | 63187055490 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-554-90) | 2015-09-01 | 0000-00-00 | No | No | Current |