68308-220 : Esgic Oral Tablet

NDC:	68308-220
Labeler:	Midlothian Laboratories
Product Type:	Human Prescription Drug
Drug Name:	Esgic
Dosage Form:	Oral Tablet
Application #:	ANDA089175
Rev. Date:	May 1, 2014
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:	535;11
Shapes:	Oval
Colors:	White
Size (mm):	14
Segments: *	2
* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

• 68308-220-01: 100 TABLET IN 1 BOTTLE, PLASTIC (68308‑220‑01)

Active Ingredients:

• Acetaminophen
• Butalbital
• Caffeine

Inactive Ingredients:

• Cellulose, Microcrystalline
• Croscarmellose Sodium
• Crospovidone
• Povidones
• Silicon Dioxide
• Starch, Corn
• Stearic Acid

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.

• 68308-219 Esgic Oral Capsule by Midlothian Laboratories
• 0535-0011 Esgic (Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg) Oral Tablet by Forest Laboratories, Inc.
• 0535-0012 Esgic (Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg) Oral Capsule by Forest Laboratories, Inc.

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