0095-3000 : Apap 300 mg / Butalbital 50 mg Oral Tablet [bupap]

NDC:	0095-3000
Labeler:	Ecr Pharmaceuticals
Product Type:	Human Prescription Drug
Drug Name:	Bupap
Dosage Form:	Oral Tablet
Application #:	ANDA090956
Rev. Date:	Jun 24, 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:	BA;300
Shapes:	Round
Colors:	Yellow
Size (mm):	12
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:

• 0095-3000-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0095‑3000‑01)
• 0095-3000-09: 1 TABLET IN 1 POUCH (0095‑3000‑09)

Active Ingredients:

• Butalbital
• Acetaminophen

Inactive Ingredients:

• Starch, Corn
• Cellulose, Microcrystalline
• Croscarmellose Sodium
• Magnesium Stearate
• D&c Yellow No. 10
• Fd&c Red No. 40

Pharmaceutical Classes:

• Barbiturates [CS]
• Barbiturate [EPC]

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