Mirtazapine
- Product NDC
- 57664-501
- 11-digit product format
- 576640501
- Labeler code
- 57664
- Product ID
- 57664-501_f5e842da-4922-4f1d-b2e0-a4c0be71e2a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA076541
- Marketing category
- ANDA
- Marketing start
- 2004-04-22
- 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, 476809 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 57664-501-18 | Mirtazapine | 1000 in 1 BOTTLE | TABLET | 1000 | | 11 |
| 57664-501-83 | Mirtazapine | 30 in 1 BOTTLE | TABLET | 30 | | 11 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| mirtazapine | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| mirtazapine | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| colloidal silicon dioxide | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| corn starch | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| hydroxypropyl cellulose | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| hypromellose 2910 | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| iron oxide yellow | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| iron oxides yellow | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| lactose monohydrate | INACTIVE INGREDIENT | EWQ57Q8I5X | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| magnesium stearate | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| opadry 20A52767 (yellow colored film) | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| opadry 20A56666 (reddish brown colored film) | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| opadry 20A58916 (white colored film) | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| pregelatinized starch | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| red and black | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| titanium dioxde | INACTIVE INGREDIENT | | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| titanium dioxide | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE (MIRTAZAPINE) TABLET [CARACO PHARMACEUTICAL LABORATORIES, LTD.] | 3 | |
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| HYPROMELLOSE | INACTIVE INGREDIENT | 3NXW29V3WO | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57664-501 | MIRTAZAPINE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 11 | Current NDC, Legacy NDC, 2 package rows | 20220126_f23631be-c7ae-46e9-b771-a70be17bc9f0.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 |
|---|
| 57664-501-18 | 57664050118 | 1000 TABLET in 1 BOTTLE (57664-501-18) | 1000 tablet | 2017-04-22 | 0000-00-00 | No | No | Current |
| 57664-501-83 | 57664050183 | 30 TABLET in 1 BOTTLE (57664-501-83) | 30 tablet | 2004-04-22 | 0000-00-00 | No | No | Current |