0591-3494 : Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet

NDC:	0591-3494
Labeler:	Watson Laboratories, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Oxycodone Hydrochloride and Ibuprofen
Dosage Form:	Oral Tablet
Application #:	ANDA078394
Rev. Date:	Dec 1, 2007
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:	34;94;WATSON
Shapes:	Oval
Colors:	White
Size (mm):	18
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:

• 0591-3494-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0591‑3494‑01)
• 0591-3494-05: 500 TABLET IN 1 BOTTLE, PLASTIC (0591‑3494‑05)
• 0591-3494-30: 30 TABLET IN 1 BOTTLE, PLASTIC (0591‑3494‑30)

Active Ingredients:

• Ibuprofen
• Oxycodone Hydrochloride

Inactive Ingredients:

• Sodium Starch Glycolate Type a Potato
• Cellulose, Microcrystalline
• Silicon Dioxide
• Stearic Acid
• Carboxymethylcellulose Sodium
• Lactose Monohydrate
• Talc
• Titanium Dioxide
• Polydextrose
• Hypromelloses
• Triacetin
• Polyethylene Glycol 400
• Polyethylene Glycol 8000

Pharmaceutical Classes:

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Cyclooxygenase Inhibitors [MoA]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]

Related Products:

Based on records with the same trade name.

• 0228-4029 Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Actavis Elizabeth LLC
• 0555-0778 Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Barr Laboratories Inc.
• 35356-561 Ibuprofen 400 mg / Oxycodone Hydrochloride 5 mg Oral Tablet by Lake Erie Medical Dba Quality Care Products LLC

NDC QR Code

Scan the QR code below to easily reference this data in the future:



< Prev: 0591-3468Next: 0591-3496 >

Related Discussions: