Mirtazapine
- Product NDC
- 68084-119
- 11-digit product format
- 680840119
- Labeler code
- 68084
- Product ID
- 68084-119_237f93fe-0241-f4a1-e063-6394a90a2ce9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- American Health Packaging
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2005-10-31
- Substance
- MIRTAZAPINE
- Active strength
- 15 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 | 15 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | A051Q2099Q |
| Rxcui | 311725, 311726, 314111 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68084-119-01 | Mirtazapine | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 14 |
| 68084-119-11 | Mirtazapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Mirtazapine | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| Mirtazapine | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| HYDROXYPROPYL CELLULOSE (TYPE H) | INACTIVE INGREDIENT | RFW2ET671P | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68084-119 | MIRTAZAPINE TABLET, FILM COATED [AMERICAN HEALTH PACKAGING] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241004_82a615a0-e74a-49cb-9a57-ffbb3df604d5.zip |
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 |
|---|
| 68084-119-01 | 68084011901 | 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-119-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-119-11) | 100 blister pack | 2005-10-31 | 0000-00-00 | No | No | Current |
| 68084-119-11 | 68084011911 | 1 in 1 BLISTER PACK | | | | | | Historical |