Mirtazapine
- Product NDC
- 57237-007
- 11-digit product format
- 572370007
- Labeler code
- 57237
- Product ID
- 57237-007_7616f3f3-c42e-474d-b201-0235120cff36
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Rising Pharma Holdings, Inc.
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2004-10-22
- Substance
- MIRTAZAPINE
- Active strength
- 7.5 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 | 7.5 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 |
|---|
| 57237-007-05 | Mirtazapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 15 |
| 57237-007-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| MIRTAZAPINE | ACTIVE INGREDIENT | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| MIRTAZAPINE | ACTIVE MOIETY | A051Q2099Q | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| FERRIC OXIDE RED | INACTIVE INGREDIENT | 1K09F3G675 | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| FERROSOFERRIC OXIDE | INACTIVE INGREDIENT | XM0M87F357 | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE | INACTIVE INGREDIENT | RFW2ET671P | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED | INACTIVE INGREDIENT | 2165RE0K14 | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | MIRTAZAPINE TABLET, FILM COATED [CITRON PHARMA LLC] | 2 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 57237-007 | MIRTAZAPINE TABLET, FILM COATED [RISING PHARMA HOLDINGS, INC.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240203_58e9b4c6-531f-49c4-a640-6953e70892fe.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 |
|---|
| 57237-007-05 | 57237000705 | 500 TABLET, FILM COATED in 1 BOTTLE (57237-007-05) | 2004-10-22 | 0000-00-00 | No | No | Current |
| 57237-007-30 | 57237000730 | 30 TABLET, FILM COATED in 1 BOTTLE (57237-007-30) | 2004-10-22 | 0000-00-00 | No | No | Current |