Mirtazapine
- Product NDC
- 68071-4989
- 11-digit product format
- 680714989
- Labeler code
- 68071
- Product ID
- 68071-4989_1b305c50-b2f3-6e01-e063-6394a90a0ce1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- NuCare Pharmaceuticals,Inc.
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2004-10-22
- 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#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 68071-4989-3 | 2024-06-26 | C162847 | 48780-1 | ba0f9c33-1290-a910-e053-dadaa90a0b85 | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only |
| 68071-4989-3 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-1290-a910-e053-dadaa90a0b85 | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only |
| 68071-4989-3 | 2021-02-19 | C162847 | 48780-1 | ba0f9c33-1290-a910-e053-dadaa90a0b85 | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only |
| 68071-4989-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-1290-a910-e053-dadaa90a0b85 | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx only |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68071-4989-3 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68071-4989 | MIRTAZAPINE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20240627_8e839bb2-2f67-f224-e053-2a95a90ae5d8.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 |
|---|
| 68071-4989-3 | 68071498903 | 30 TABLET, FILM COATED in 1 BOTTLE (68071-4989-3) | 2019-07-25 | 0000-00-00 | No | No | Current |