51862-544 : Butalbital and Acetaminophen Oral Capsule

NDC:	51862-544
Labeler:	Mayne Pharma
Product Type:	Human Prescription Drug
Drug Name:	Butalbital and Acetaminophen
Dosage Form:	Oral Capsule
Application #:	ANDA207313
Rev. Date:	Jul 30, 2018
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:	mayne;544
Shapes:	Capsule
Colors:	Purple
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:

• 51862-544-01: 100 CAPSULE IN 1 BOTTLE (51862‑544‑01)
• 51862-544-05: 500 CAPSULE IN 1 BOTTLE (51862‑544‑05)

Active Ingredients:

• Butalbital
• Acetaminophen

Inactive Ingredients:

• Croscarmellose Sodium
• Crospovidone
• Cellulose, Microcrystalline
• Silicon Dioxide
• Stearic Acid
• Povidone, Unspecified
• Starch, Corn
• Gelatin
• Titanium Dioxide
• Fd&c Blue No. 1
• Fd&c Red No. 3 /

Pharmaceutical Classes:

• Barbiturates [CS]
• Barbiturate [EPC]

Related Products:

Based on records with the same trade name.

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