64850-633 : Hydrocodone Bitartrate and Acetaminophen Oral Tablet

NDC:	64850-633
Labeler:	Elite Laboratories, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hydrocodone Bitartrate and Acetaminophen
Dosage Form:	Oral Tablet
Application #:	ANDA209924
Rev. Date:	Nov 16, 2018
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.

Appearance:

Markings:	EH;CA;10;325
Shapes:	Capsule
Colors:	White
Size (mm):	14
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 64850-633-01: 100 TABLET IN 1 BOTTLE, PLASTIC (64850‑633‑01)
• 64850-633-30: 30 TABLET IN 1 BOTTLE, PLASTIC (64850‑633‑30)
• 64850-633-60: 60 TABLET IN 1 BOTTLE, PLASTIC (64850‑633‑60)
• 64850-633-90: 90 TABLET IN 1 BOTTLE, PLASTIC (64850‑633‑90)

Active Ingredients:

• Hydrocodone Bitartrate
• Acetaminophen

Inactive Ingredients:

• Cellulose, Microcrystalline
• Talc
• Croscarmellose Sodium
• Magnesium Stearate /

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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