71335-9603 : Butalbital, Acetaminophen and Caffeine Oral Tablet

NDC:	71335-9603
Labeler:	Bryant Ranch Prepack
Product Type:	Human Prescription Drug
Drug Name:	Butalbital, Acetaminophen and Caffeine
Dosage Form:	Oral Tablet
Application #:	ANDA211106
Rev. Date:	Sep 26, 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.

NDC Package Codes:

• 71335-9603-0: 84 TABLET IN 1 BOTTLE (71335‑9603‑0)
• 71335-9603-1: 20 TABLET IN 1 BOTTLE (71335‑9603‑1)
• 71335-9603-2: 30 TABLET IN 1 BOTTLE (71335‑9603‑2)
• 71335-9603-3: 60 TABLET IN 1 BOTTLE (71335‑9603‑3)
• 71335-9603-4: 90 TABLET IN 1 BOTTLE (71335‑9603‑4)
• 71335-9603-5: 50 TABLET IN 1 BOTTLE (71335‑9603‑5)
• 71335-9603-6: 6 TABLET IN 1 BOTTLE (71335‑9603‑6)
• 71335-9603-7: 120 TABLET IN 1 BOTTLE (71335‑9603‑7)
• 71335-9603-8: 40 TABLET IN 1 BOTTLE (71335‑9603‑8)
• 71335-9603-9: 12 TABLET IN 1 BOTTLE (71335‑9603‑9)

Active Ingredients:

• Acetaminophen
• Butalbital
• Caffeine

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.

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• 71335-0365 Butalbital, Acetaminophen, and Caffeine Oral Tablet by Bryant Ranch Prepack
• 71335-1977 Butalbital, Acetaminophen and Caffeine Oral Tablet by Bryant Ranch Prepack
• 71335-2270 Butalbital, Acetaminophen and Caffeine Oral Tablet by Bryant Ranch Prepack
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• 63629-2140 Butalbital, Acetaminophen and Caffeine Oral Tablet by Bryant Ranch Prepack
• 63629-2151 Butalbital, Acetaminophen and Caffeine Oral Tablet by Bryant Ranch Prepack
• 63629-2372 Butalbital, Acetaminophen and Caffeine Oral Capsule by Bryant Ranch Prepack
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• 72162-1096 Butalbital, Acetaminophen and Caffeine Oral Capsule by Bryant Ranch Prepack
• 72162-1232 Butalbital, Acetaminophen and Caffeine Oral Capsule by Bryant Ranch Prepack
• 0143-0170 Butalbital, Acetaminophen, and Caffeine Oral Capsule by West-ward Pharmaceutical Corp
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• 0143-1787 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by West-ward Pharmaceutical Corp
• 0179-0137 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Kaiser Foundation Hospitals
• 0527-1695 Apap 325 mg / Butalbital 50 mg / Caffeine 40 mg Oral Tablet by Lannett Company, Inc.
• 0527-4094 Butalbital, Acetaminophen and Caffeine Oral Capsule by Lannett Company, Inc.
• 0527-4095 Butalbital, Acetaminophen, and Caffeine Oral Capsule by Lannett Company, Inc.
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