NDC 0603-2553

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 Par Pharmaceutical. The primary component is Butalbital; Acetaminophen; Caffeine; Codeine Phosphate.

• Product ID: 0603-2553_19a12026-cf90-4644-9b09-7344c651d74e
• NDC: 0603-2553
• 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: 2002-04-22
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075929
• Labeler Name: Par Pharmaceutical
• 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
• DEA Schedule: CIII
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0603-2553-21

100 CAPSULE in 1 BOTTLE, PLASTIC (0603-2553-21)

• Marketing Start Date: 2002-04-22
• Marketing End Date: 2022-09-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0603-2553-10 [00603255310]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075929
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-04-22
• Marketing End Date: 2014-09-18

NDC 0603-2553-32 [00603255332]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075929
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2002-04-22
• Marketing End Date: 2014-09-18

NDC 0603-2553-21 [00603255321]

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate CAPSULE

• Marketing Category: ANDA
• Application Number: ANDA075929
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-04-22

Drug Details

Active Ingredients

Ingredient	Strength
BUTALBITAL	50 mg/1

OpenFDA Data

• SPL SET ID: 6f8cced0-4749-4a11-8f00-96d8c23c1cfd
• Manufacturer:
  • Par Pharmaceutical
• UNII:
  • KHS0AZ4JVK
  • 362O9ITL9D
  • 3G6A5W338E
  • GSL05Y1MN6
• RxNorm Concept Unique ID - RxCUI:
  • 993943
• UPC Code:
  • 0306032553218

Pharmacological Class

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

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