NDC 68258-2012

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 Dispensing Solutions, Inc.. The primary component is Butalbital; Acetaminophen; Caffeine; Codeine Phosphate.

• Product ID: 68258-2012_602e7e89-3dfe-40fe-82ae-de285a2496f6
• NDC: 68258-2012
• 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: 2004-07-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA076560
• Labeler Name: Dispensing Solutions, Inc.
• Substance Name: BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
• Active Ingredient Strength: 50 mg/1; mg/1; mg/1; mg/1
• Pharm Classes: Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
• DEA Schedule: CIII
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 68258-2012-9

90 CAPSULE in 1 BOTTLE, PLASTIC (68258-2012-9)

• Marketing Start Date: 2004-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68258-2012-9 [68258201209]

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA076560
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2004-07-01
• Inactivation Date: 2019-11-13

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: 7fd761e6-64fe-44cc-8b74-10ce31ccfd66
• Manufacturer:
  • Dispensing Solutions, Inc.
• UNII:
  • KHS0AZ4JVK
  • 362O9ITL9D
  • 3G6A5W338E
  • GSL05Y1MN6
• RxNorm Concept Unique ID - RxCUI:
  • 993943

Pharmacological Class

• 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
0054-0650	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
0054-3000	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
51991-073	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
68258-2012	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
71335-0194	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate	Butalbital, Acetaminophen, Caffeine and Codeine Phosphate