Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Product NDC
0722-7028
11-digit product format
007227028
Labeler code
0722
Product ID
0722-7028_9465cf48-74b4-4615-83ef-4a3724c5f9e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Nexgen Pharma, Inc.
Application
ANDA076560
Marketing category
ANDA
Marketing start
2004-06-10
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
Active strength
50 mg/1; mg/1; mg/1; mg/1
Pharmacologic 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
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0722-7028-01Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate100 in 1 BOTTLE, PLASTICCAPSULE10011
0722-7028-05Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate500 in 1 BOTTLE, PLASTICCAPSULE50011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
GELATININACTIVE INGREDIENT2G86QN327LBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0722-7028BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [NEXGEN PHARMA, INC.]11Legacy NDC, 2 package rows20200223_8f8c5c01-5859-4843-adf4-8116ddaedc90.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1431286butalbital 50 MG / acetaminophen 300 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN8f8c5c01-5859-4843-adf4-8116ddaedc9011
1431286acetaminophen 300 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD8f8c5c01-5859-4843-adf4-8116ddaedc9011
1431286APAP 300 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral CapsuleSY8f8c5c01-5859-4843-adf4-8116ddaedc9011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0722-7028-0100722702801100 CAPSULE in 1 BOTTLE, PLASTIC (0722-7028-01) 100 capsule2004-06-100000-00-00NoNoCurrent
0722-7028-0500722702805500 CAPSULE in 1 BOTTLE, PLASTIC (0722-7028-05) 500 capsule2004-06-100000-00-00NoNoCurrent