NDC 0093-4161 – Amoxicillin
Amoxicillin 400 mg/5mL · Powder, For Suspension · Oral
Product NDC0093-4161
Product details
- Brand name
- Amoxicillin
- Generic name
- Amoxicillin
- Labeler
- Teva Pharmaceuticals USA, Inc.
- Dosage form
- Powder, For Suspension
- Route
- Oral
- Marketing category
- ANDA · ANDA065119
- Marketed since
- February 26, 2003
- Listing expires
- December 31, 2026
- Pharmacologic class
- Penicillin-class Antibacterial
Active ingredients
- Amoxicillin 400 mg/5mL
Package NDC codes (3)
| Package NDC | Description | Since |
|---|---|---|
| 0093-4161-73 | 100 mL in 1 BOTTLE (0093-4161-73) | Feb 26, 2003 |
| 0093-4161-76 | 50 mL in 1 BOTTLE (0093-4161-76) | Jul 1, 2003 |
| 0093-4161-78 | 75 mL in 1 BOTTLE (0093-4161-78) | Jul 1, 2003 |
Recalls mentioning this NDC
- D-0165-2024 Jan 3, 2024 · Class II
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions. - D-1470-2016 Aug 31, 2016 · Class II
Superpotent drug: Out of specification test result for assay during stability testing. - D-803-2013 Jul 24, 2013 · Class III
Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050. - D-598-2013 Jun 19, 2013 · Class III
Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.
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