Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Product NDC
51991-073
11-digit product format
519910073
Labeler code
51991
Product ID
51991-073_2e57797a-2cd4-4f32-ae8b-2db74f699b61
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA076560
Marketing category
ANDA
Marketing start
2004-07-01
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength
325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
BUTALBITAL50 mg/1
CAFFEINE40 mg/1
CODEINE PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6
Rxcui993943

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-073-01Butalbital, Acetaminophen, Caffeine and Codeine Phosphate100 in 1 BOTTLE, PLASTICCAPSULE10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-073-01EA - Each51991-073663eab42-79d4-4653-bc98-0fe9ec4d3f1212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetaminophenACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
AcetaminophenACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
ButalbitalACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
ButalbitalACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
CaffeineACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
CaffeineACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
AcetaminophenACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
ButalbitalACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
ButalbitalACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
CaffeineACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
CaffeineACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
CodeineACTIVE MOIETYQ830PW7520BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
CodeineACTIVE MOIETYQ830PW7520BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOABUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOABUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
GelatinINACTIVE INGREDIENT2G86QN327LBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
GelatinINACTIVE INGREDIENT2G86QN327LBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]2
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPBUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [DISPENSING SOLUTIONS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-073BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]11Current NDC, Legacy NDC, 1 package rows20250115_d74db417-d2de-495b-bb75-46a83745603d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993943butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN215e2a6f-ec32-4836-8fad-22c8b40ba1f1101
993943acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD215e2a6f-ec32-4836-8fad-22c8b40ba1f1101
993943APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY215e2a6f-ec32-4836-8fad-22c8b40ba1f1101
993943butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSNd74db417-d2de-495b-bb75-46a83745603d11
993943acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCDd74db417-d2de-495b-bb75-46a83745603d11
993943APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSYd74db417-d2de-495b-bb75-46a83745603d11
993943butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN15a34df5-e48f-4570-9232-80e4093c462410
993943acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD15a34df5-e48f-4570-9232-80e4093c462410
993943APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY15a34df5-e48f-4570-9232-80e4093c462410
993943butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN7fd761e6-64fe-44cc-8b74-10ce31ccfd662
993943acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD7fd761e6-64fe-44cc-8b74-10ce31ccfd662
993943APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY7fd761e6-64fe-44cc-8b74-10ce31ccfd662

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-073-0151991007301100 CAPSULE in 1 BOTTLE, PLASTIC (51991-073-01) 100 capsule2004-07-010000-00-00NoNoCurrent