55700-991 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	55700-991
Labeler:	Quality Care Products, LLC
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA040400
Rev. Date:	Dec 27, 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:

55700-991-30: 30 TABLET IN 1 BOTTLE (55700‑991‑30)
55700-991-60: 60 TABLET IN 1 BOTTLE (55700‑991‑60)
55700-991-90: 90 TABLET IN 1 BOTTLE (55700‑991‑90)

Active Ingredients:

Acetaminophen
Hydrocodone Bitartrate

Dosage Strength:

325 mg
10 mg

Pharmaceutical Classes:

Opioid Agonist [EPC]
Opioid Agonists [MoA]

NDC QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.