70518-3491 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	70518-3491
Labeler:	Remedyrepack Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA209036
Rev. Date:	Aug 22, 2022
CSA Schedule:	CII (US) [1]

^[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 70518-3491-0: 100 POUCH IN 1 BOX (70518‑3491‑0) > 1 TABLET IN 1 POUCH (70518‑3491‑1)

Active Ingredients:

• Acetaminophen
• Hydrocodone Bitartrate

Pharmaceutical Classes:

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

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