NDC 13107-059 – Acetaminophen and Codeine Phosphate
Acetaminophen 300 mg/1; Codeine Phosphate 30 mg/1 · Tablet · Oral
Product NDC13107-059
Product details
- Brand name
- Acetaminophen and Codeine Phosphate
- Generic name
- Acetaminophen and Codeine Phosphate
- Labeler
- Aurolife Pharma, LLC
- Dosage form
- Tablet
- Route
- Oral
- Marketing category
- ANDA · ANDA202800
- Marketed since
- April 15, 2013
- Listing expires
- December 31, 2026
- Pharmacologic class
- Opioid Agonist
Active ingredients
- Acetaminophen 300 mg/1
- Codeine Phosphate 30 mg/1
Uses, dosage, side effects and warnings for Acetaminophen and Codeine Phosphate →
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 13107-059-01 | 100 TABLET in 1 BOTTLE (13107-059-01) | Apr 15, 2013 |
| 13107-059-05 | 500 TABLET in 1 BOTTLE (13107-059-05) | Apr 15, 2013 |
| 13107-059-30 | 30 TABLET in 1 BOTTLE (13107-059-30) | Apr 15, 2013 |
| 13107-059-99 | 1000 TABLET in 1 BOTTLE (13107-059-99) | Apr 15, 2013 |
Recalls mentioning this NDC
- D-1231-2020 Apr 22, 2020 · Class II
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-1230-2020 Apr 22, 2020 · Class II
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-1229-2020 Apr 22, 2020 · Class II
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed - D-0806-2018 May 23, 2018 · Class II
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to…
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