NDC 60219-2348 – Tramadol Hydrochloride
Tramadol Hydrochloride 50 mg/1 · Tablet, Coated · Oral
Product NDC60219-2348
Product details
- Brand name
- Tramadol Hydrochloride
- Generic name
- Tramadol Hydrochloride
- Labeler
- Amneal Pharmaceuticals NY LLC
- Dosage form
- Tablet, Coated
- Route
- Oral
- Marketing category
- ANDA · ANDA076003
- Marketed since
- February 13, 2023
- Listing expires
- December 31, 2027
- Pharmacologic class
- Opioid Agonist
Active ingredients
- Tramadol Hydrochloride 50 mg/1
Uses, dosage, side effects and warnings for Tramadol Hydrochloride →
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 60219-2348-1 | 100 TABLET, COATED in 1 BOTTLE (60219-2348-1) | Feb 13, 2023 |
| 60219-2348-4 | 10 TABLET, COATED in 1 BOTTLE (60219-2348-4) | Feb 13, 2023 |
| 60219-2348-5 | 500 TABLET, COATED in 1 BOTTLE (60219-2348-5) | Feb 13, 2023 |
| 60219-2348-7 | 1000 TABLET, COATED in 1 BOTTLE (60219-2348-7) | Feb 13, 2023 |
Recalls mentioning this NDC
- D-0408-2026 Apr 8, 2026 · Class II
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
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