NDC 0456-2402 – Saphris
Asenapine Maleate 2.5 mg/1 · Tablet · Sublingual
Product NDC0456-2402
Product details
- Brand name
- Saphris
- Generic name
- Asenapine Maleate
- Labeler
- Allergan, Inc.
- Dosage form
- Tablet
- Route
- Sublingual
- Marketing category
- NDA · NDA022117
- Marketed since
- December 30, 2014
- Listing expires
- December 31, 2026
- Pharmacologic class
- Atypical Antipsychotic
Active ingredients
- Asenapine Maleate 2.5 mg/1
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0456-2402-10 sample | 1 CASE in 1 CARTON (0456-2402-10) / 1 BLISTER PACK in 1 CASE / 10 TABLET in 1 BLISTER PACK | Dec 30, 2014 |
| 0456-2402-60 | 6 CASE in 1 CARTON (0456-2402-60) / 1 BLISTER PACK in 1 CASE (0456-2402-06) / 10 TABLET in 1 BLISTER PACK | Dec 30, 2014 |
| 0456-2402-63 | 10 BLISTER PACK in 1 CARTON (0456-2402-63) / 10 TABLET in 1 BLISTER PACK (0456-2402-11) | Dec 30, 2014 |
Recalls mentioning this NDC
- D-0880-2017 Jun 7, 2017 · Class II
Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets