Mirtazapine
- Product NDC
- 17856-0101
- 11-digit product format
- 178560101
- Labeler code
- 17856
- Product ID
- 17856-0101_3892e59b-daa3-17b8-e063-6394a90a00f5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Mirtazapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- ATLANTIC BIOLOGICALS CORP.
- Application
- ANDA076921
- Marketing category
- ANDA
- Marketing start
- 2009-08-17
- 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 | 476809 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
NDC, Effective, Action table| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|
| 17856-0101-1 | 2025-04-03 | C162847 | 48780-1 | f386c649-a5c0-0266-e053-dadaa90a7c1a | Mirtazapine Tablets, USP 7.5 mg, 15 mg, 30 mg, and 45 mg Rx Only |
| 17856-0101-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-a5c0-0266-e053-dadaa90a7c1a | 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 |
|---|
| 17856-0101-1 | Mirtazapine | 100 in 1 BOX, UNIT-DOSE | TABLET, FILM COATED | 100 | | 4 |
| 17856-0101-1 | Mirtazapine | 1 in 1 POUCH | TABLET, FILM COATED | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17856-0101 | MIRTAZAPINE TABLET, FILM COATED [ATLANTIC BIOLOGICALS CORP.] | 2 | Current NDC, Legacy NDC, 2 package rows | 20250406_e6e5cbf7-a958-4ef8-abcc-a7491edb9520.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 |
|---|
| 17856-0101-1 | 17856010101 | 100 POUCH in 1 BOX, UNIT-DOSE (17856-0101-1) / 1 TABLET, FILM COATED in 1 POUCH | 100 pouch | 2021-05-12 | 0000-00-00 | No | No | Current |