NDC 72189-343
Hydrocodone Bitartrate And Acetaminophen 5 mg / 325 mg tablet
On the label: Direct Rx. It's repackaged: Direct Rx rebottles it from Camber Pharmaceuticals Inc.'s NDC 31722-996.
Where the pills inside were made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Ascent Pharmaceuticals Inc | Central Islip, NY, United States | Makes it, tests it and packages it | Problems found, fixed voluntarilyAug 9, 2024 · 9 inspections |
Repackaging site
- Direct Rx, Dawsonville, GA, United States · relabels it
Recalls
- Nov 19, 2021 · Class II · Ascent Pharmaceuticals, Inc.
Product Mix-up
Lots: Lot #: 21070817, Exp 6/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetaminophen and Hydrocodone: every company that makes it
- Form
- tablet, oral
- Strength
- 5 mg / 325 mg
- Approval
- ANDA ANDA211487
- On the market since
- Mar 30, 2022
- Package NDCs
72189-343-0872189-343-2072189-343-3072189-343-6072189-343-7272189-343-90- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2025
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?