NDC 70069-383 – Haloperidol Decanoate
Haloperidol Decanoate 100 mg/mL · Injection · Intramuscular
Product NDC70069-383
Product details
- Brand name
- Haloperidol Decanoate
- Generic name
- Haloperidol Decanoate
- Labeler
- Somerset Therapeutics, LLC
- Dosage form
- Injection
- Route
- Intramuscular
- Marketing category
- ANDA · ANDA209101
- Marketed since
- April 4, 2019
- Listing expires
- December 31, 2026
- Pharmacologic class
- Typical Antipsychotic
Active ingredients
- Haloperidol Decanoate 100 mg/mL
Uses, dosage, side effects and warnings for Haloperidol Decanoate →
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 70069-383-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-01) / 1 mL in 1 VIAL, SINGLE-DOSE | Oct 4, 2019 |
| 70069-383-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-05) / 1 mL in 1 VIAL, SINGLE-DOSE | Apr 4, 2019 |
| 70069-383-10 | 10 VIAL, SINGLE-DOSE in 1 CARTON (70069-383-10) / 1 mL in 1 VIAL, SINGLE-DOSE | Apr 13, 2019 |
Recalls mentioning this NDC
- D-0358-2025 Apr 16, 2025 · Class II
Lack of Assurance of Sterility: Media fill with bacterial contamination - D-0355-2025 Apr 16, 2025 · Class II
Lack of Assurance of Sterility: Media fill with bacterial contamination - D-0506-2024 May 29, 2024 · Class II
Presence of Foreign Substance: This oil based product may contain trace amounts of water for injection (WFI).
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