NDC 0591-3220

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Codeine Phosphate; Butalbital; Caffeine; Acetaminophen.

• Product ID: 0591-3220_91a4b0d2-3c8f-4cf9-8684-ea0d1d940873
• NDC: 0591-3220
• Product Type: Human Prescription Drug
• Proprietary Name: Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
• Generic Name: Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2003-09-18
• Marketing Category: NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
• Application Number: NDA020232
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN
• Active Ingredient Strength: 30 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0591-3220-01

100 CAPSULE in 1 BOTTLE (0591-3220-01)

• Marketing Start Date: 2003-09-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3220-01 [00591322001]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE

• Marketing Category: NDA AUTHORIZED GENERIC
• Application Number: NDA020232
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-09-18

Drug Details

Active Ingredients

Ingredient	Strength
CODEINE PHOSPHATE	30 mg/1

OpenFDA Data

• SPL SET ID: a58819b8-a52c-44a7-9ab0-c74480d98506
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • GSL05Y1MN6
  • KHS0AZ4JVK
  • 3G6A5W338E
  • 362O9ITL9D
• RxNorm Concept Unique ID - RxCUI:
  • 993943
• UPC Code:
  • 0305913220010

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Barbiturates [CS]
• Barbiturate [EPC]
• Central Nervous System Stimulant [EPC]
• Methylxanthine [EPC]
• Xanthines [CS]
• Central Nervous System Stimulation [PE]

NDC Crossover Matching brand name "Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate" or generic name "Butalbital, Acetaminophen, Caffeine, And Codeine Phosphate"

NDC	Brand Name	Generic Name
0591-2641	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
0591-3220	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
0603-2553	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
0722-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
0722-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
63629-3152	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
71335-0653	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
79739-6670	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
79739-7028	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
52544-082	Fioricet with Codeine	Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate