NDC 47335-308 – Zolpidem Tartrate
Zolpidem Tartrate 12.5 mg/1 · Tablet, Film Coated, Extended Release · Oral
Product NDC47335-308
Product details
- Brand name
- Zolpidem Tartrate
- Generic name
- Zolpidem Tartrate
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Dosage form
- Tablet, Film Coated, Extended Release
- Route
- Oral
- Marketing category
- ANDA · ANDA204170
- Marketed since
- May 15, 2017
- Listing expires
- December 31, 2026
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic Agonist
Active ingredients
- Zolpidem Tartrate 12.5 mg/1
Uses, dosage, side effects and warnings for Zolpidem tartrate →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 47335-308-13 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-13) | May 15, 2017 |
| 47335-308-88 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-308-88) | May 15, 2017 |
Recalls mentioning this NDC
- D-0271-2024 Jan 31, 2024 · Class II
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. - D-0272-2024 Jan 31, 2024 · Class II
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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