70010-044 : Butalbita,acetaminophen and Caffeine Oral Capsule

NDC:	70010-044
Labeler:	Granules Pharmaceuticals Inc.
Product Type:	Human Prescription Drug
Drug Name:	Butalbita,acetaminophen and Caffeine
Dosage Form:	Oral Capsule
Application #:	ANDA213321
Rev. Date:	May 5, 2020
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:	GPI;50;300;40;044
Shapes:	Capsule
Colors:	Blue
Size (mm):	24
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:

• 70010-044-01: 100 CAPSULE IN 1 BOTTLE (70010‑044‑01)
• 70010-044-05: 500 CAPSULE IN 1 BOTTLE (70010‑044‑05)

Active Ingredients:

• Butalbital
• Acetaminophen
• Caffeine

Inactive Ingredients:

• Ammonia
• Ferrosoferric Oxide
• Crospovidone
• Fd&c Blue No. 1
• Fd&c Red No. 3
• Gelatin
• Microcrystalline Cellulose
• Povidone
• Propylene Glycol
• Shellac
• Starch, Corn
• Sodium Lauryl Sulfate
• Stearic Acid
• Talc
• Titanium Dioxide /

Pharmaceutical Classes:

• Barbiturate [EPC]
• Barbiturates [CS]
• Central Nervous System Stimulant [EPC]
• Central Nervous System Stimulation [PE]
• Methylxanthine [EPC]
• Xanthines [CS]

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