Mirtazapine
- Product NDC
- 66993-608
- 11-digit product format
- 669930608
- Labeler code
- 66993
- Product ID
- 66993-608_e1a19354-1c97-49ed-8ec9-bb895dbe69f3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Prasco Laboratories
- Application
- ANDA216751
- Marketing category
- ANDA
- Marketing start
- 2023-09-01
- 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 | 311725, 311726, 314111, 476809 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 66993-608-04 | Mirtazapine | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | | 4 |
| 66993-608-30 | Mirtazapine | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 66993-608 | MIRTAZAPINE TABLET, FILM COATED [PRASCO LABORATORIES] | 4 | Current NDC, 2 package rows | 20230901_8b2a08f7-4803-42fa-a2b5-5ea51f8ef7e4.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 66993-608-04 | 66993060804 | 500 TABLET, FILM COATED in 1 BOTTLE (66993-608-04) | 2023-09-01 | No | No | Historical |
| 66993-608-30 | 66993060830 | 30 TABLET, FILM COATED in 1 BOTTLE (66993-608-30) | 2023-09-01 | No | No | Historical |