Mirtazapine
- Product NDC
- 51079-088
- 11-digit product format
- 510790088
- Labeler code
- 51079
- Product ID
- 51079-088_3a87423c-fbbb-b2a4-e063-6394a90a0db3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Mylan Institutional Inc.
- Application
- ANDA076122
- Marketing category
- ANDA
- Marketing start
- 2003-08-01
- Substance
- MIRTAZAPINE
- Active strength
- 45 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 | 45 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 |
|---|
| 51079-088-01 | Mirtazapine | 1 in 1 BLISTER PACK | TABLET, FILM COATED | 1 | | 16 |
| 51079-088-20 | Mirtazapine | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 16 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| ANHYDROUS LACTOSE | INACTIVE INGREDIENT | 3SY5LH9PMK | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| FD&C BLUE NO. 2 | INACTIVE INGREDIENT | L06K8R7DQK | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| HYPROMELLOSES | INACTIVE INGREDIENT | 3NXW29V3WO | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| SODIUM LAURYL SULFATE | INACTIVE INGREDIENT | 368GB5141J | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 5 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51079-088 | MIRTAZAPINE TABLET, FILM COATED [MYLAN INSTITUTIONAL INC.] | 15 | Current NDC, Legacy NDC, 2 package rows | 20241011_6837b69b-2f86-42cf-b48d-b4a3c7b5413f.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 |
|---|
| 51079-088-01 | 51079008801 | 1 in 1 BLISTER PACK | | | | | | Historical |
| 51079-088-20 | 51079008820 | 100 BLISTER PACK in 1 CARTON (51079-088-20) / 1 TABLET, FILM COATED in 1 BLISTER PACK (51079-088-01) | 100 blister pack | 2003-08-01 | 0000-00-00 | No | No | Current |