65084-454 : Fioricet Oral Capsule

NDC:	65084-454
Labeler:	Rx Pak Division of Mckesson Corporation
Product Type:	Human Prescription Drug
Drug Name:	Fioricet
Dosage Form:	Oral Capsule
Application #:	ANDA040885
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
Shapes:	Capsule
Colors:	Blue / Blue
Size (mm):	13
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:

• 65084-454-10: 100 CAPSULE IN 1 BOTTLE (65084‑454‑10)

Active Ingredients:

• Acetaminophen
• Butalbital
• Caffeine

Pharmaceutical Classes:

• Barbiturate [EPC]
• Barbiturates [Chemical/Ingredient]
• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]
• Methylxanthine [EPC]
• Xanthines [Chemical/Ingredient]

Related Products:

Based on records with the same trade name.

• 52544-080 Fioricet (Acetaminophen 300 mg / Butalbital 50 mg / Caffeine 40 mg) Oral Capsule by Watson Pharma, Inc.
• 52544-957 Fioricet Oral Tablet by Watson Pharma, Inc.
• 55154-3416 Fioricet (Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg) Oral Tablet by Cardinal Health

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