Hydrocodone Bitartrate and Acetaminophen (HYDROCODONE BITARTRATE and ACETAMINOPHEN)

**Product type:** Human Prescription Drug

**Active ingredient:** ACETAMINOPHEN; HYDROCODONE BITARTRATE

**Strength:** 108; 2.5 mg/5mL; mg/5mL

**Dosage form:** Solution

**Route:** Oral

**Labeler:** PAI Holdings, LLC dba PAI Pharma

**Marketing category:** ANDA (ANDA040838)

**Pharmacologic class:** Opioid Agonist [EPC], Opioid Agonists [MoA]

**DEA schedule:** CII