NDC 13107-003 – Mirtazapine
Mirtazapine 30 mg/1 · Tablet, Film Coated · Oral
Product NDC13107-003
Product details
- Brand name
- Mirtazapine
- Generic name
- Mirtazapine
- Labeler
- Aurolife Pharma LLC
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA076921
- Marketed since
- August 17, 2009
- Listing expires
- December 31, 2026
Active ingredients
- Mirtazapine 30 mg/1
Package NDC codes (7)
| Package NDC | Description | Since |
|---|---|---|
| 13107-003-01 | 100 TABLET, FILM COATED in 1 BOTTLE (13107-003-01) | Aug 17, 2009 |
| 13107-003-05 | 500 TABLET, FILM COATED in 1 BOTTLE (13107-003-05) | Aug 17, 2009 |
| 13107-003-30 | 30 TABLET, FILM COATED in 1 BOTTLE (13107-003-30) | Aug 17, 2009 |
| 13107-003-32 | 30 TABLET, FILM COATED in 1 BLISTER PACK (13107-003-32) | Aug 17, 2009 |
| 13107-003-34 | 30 TABLET, FILM COATED in 1 BOTTLE (13107-003-34) | Aug 17, 2009 |
| 13107-003-60 | 60 TABLET, FILM COATED in 1 BOTTLE (13107-003-60) | Aug 17, 2009 |
| 13107-003-90 | 90 TABLET, FILM COATED in 1 BOTTLE (13107-003-90) | Aug 17, 2009 |
Recalls mentioning this NDC
- D-1235-2020 Apr 22, 2020 · Class II
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-0636-2020 Dec 18, 2019 · Class I
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets. - D-0637-2020 Dec 18, 2019 · Class I
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
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