52544-082 : Fioricet With Codeine (Apap 300 mg / Butalbital 50 mg / Caffeine 40 mg / Codeine Phosphate 30 mg) Oral Capsule

NDC:	52544-082
Labeler:	Watson Pharma, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Fioricet With Codeine
Dosage Form:	Oral Capsule
Application #:	ANDA076560
Rev. Date:	Jul 29, 2013
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.

Appearance:

Markings:	FIORICET;CODEINE
Shapes:	Capsule
Colors:	Gray / Blue
Size (mm):	22
Segments: *	1
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

• 52544-082-01: 100 CAPSULE IN 1 BOTTLE, PLASTIC (52544‑082‑01)

Active Ingredients:

• Acetaminophen
• Butalbital
• Caffeine
• Codeine Phosphate

Inactive Ingredients:

• D&c Yellow No. 10
• Fd&c Blue No. 1
• Fd&c Red No. 40
• Fd&c Yellow No. 6
• Gelatin
• Cellulose, Microcrystalline
• Sodium Lauryl Sulfate
• Stearic Acid
• Talc

Pharmaceutical Classes:

• Barbiturates [CS]
• Barbiturate [EPC]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]
• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.

• 52544-958 Fioricet With Codeine Oral Capsule by Watson Pharma, Inc.

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