75907-008 : Butalbital and Acetaminophen Oral Capsule

NDC:	75907-008
Labeler:	Dr. Reddy's Labratories Inc.
Product Type:	Human Prescription Drug
Drug Name:	Butalbital and Acetaminophen
Dosage Form:	Oral Capsule
Application #:	ANDA207313
Rev. Date:	Sep 1, 2024
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.

NDC Package Codes:

• 75907-008-01: 100 CAPSULE IN 1 BOTTLE (75907‑008‑01)

Active Ingredients:

• Acetaminophen
• Butalbital

Pharmaceutical Classes:

• Barbiturate [EPC]
• Barbiturates [CS]

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