0121-4655 : Hydrocodone Bitartrate and Acetaminophen Oral Solution

NDC:	0121-4655
Labeler:	Pharmaceutical Associates, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Solution
Application #:	ANDA040182
Rev. Date:	Jan 1, 2011
CSA Schedule:	CIII (US) [1]

^[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 0121-4655-05: 4 TRAY IN 1 CASE (0121‑4655‑05) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 5 ML IN 1 CUP, UNIT‑DOSE
• 0121-4655-10: 4 TRAY IN 1 CASE (0121‑4655‑10) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 10 ML IN 1 CUP, UNIT‑DOSE
• 0121-4655-15: 4 TRAY IN 1 CASE (0121‑4655‑15) > 10 CUP, UNIT‑DOSE IN 1 TRAY > 15 ML IN 1 CUP, UNIT‑DOSE

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Pharmaceutical Classes:

• Opioid Agonist [EPC]
• Opioid Agonists [MoA]

Related Products:

Based on records with the same trade name.

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