FDA.reportPublic FDA data

BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE

Product NDC
63629-2952
11-digit product format
636292952
Labeler code
63629
Product ID
63629-2952_d68f9341-c67b-490f-96a4-806227d97343
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin, Caffeine and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075231
Marketing category
ANDA
Marketing start
2009-05-01
Substance
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
Active strength
325; 50; 40; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Opioid Agonist [EPC], Platelet Aggregation Inhibitor [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, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPIRIN325 mg/1
BUTALBITAL50 mg/1
CAFFEINE40 mg/1
CODEINE PHOSPHATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR16CO5Y76E, KHS0AZ4JVK, 3G6A5W338E, GSL05Y1MN6
Rxcui994237

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
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-2952-12020-07-21C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-22020-07-21C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-32020-07-21C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-42020-07-21C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-52020-07-21C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-62020-07-21C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-12020-01-31C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-22020-01-31C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-32020-01-31C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-42020-01-31C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-52020-01-31C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990
63629-2952-62020-01-31C16284748780-19d75b9d0-115c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ASCOMP with Codeine safely and effectively. See full prescribing information for ASCOMP with Codeine. ASCOMP with Codeine (butalbital, aspirin, caffeine, and codeine phosphate, USP) capsules, for oral use, CIII Initial U.S. Approval: 1990

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2952-1BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE30 in 1 BOTTLECAPSULE3016
63629-2952-2BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE20 in 1 BOTTLECAPSULE2016
63629-2952-3BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE90 in 1 BOTTLECAPSULE9016
63629-2952-4BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE60 in 1 BOTTLECAPSULE6016
63629-2952-5BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE40 in 1 BOTTLECAPSULE4016
63629-2952-6BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE18 in 1 BOTTLECAPSULE1816

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2952-1EA - Each63629-29524441992a-6f6c-4c3d-8866-57896ecde61e12012-07-24
63629-2952-2EA - Each63629-29529d6dc13b-5ac1-4521-9130-cfcbebc05d6112012-07-24
63629-2952-3EA - Each63629-29528310e9fa-b409-4bc8-94d9-6f1e151415c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOABUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
GELATININACTIVE INGREDIENT2G86QN327LBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2952BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]15Current NDC, Legacy NDC, 6 package rows20240602_95a33c9b-79a6-47c7-8433-fc217950b88f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
994237butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN95a33c9b-79a6-47c7-8433-fc217950b88f16
994237aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD95a33c9b-79a6-47c7-8433-fc217950b88f16
994237ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY95a33c9b-79a6-47c7-8433-fc217950b88f16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2952-16362929520130 CAPSULE in 1 BOTTLE (63629-2952-1) 30 capsule2021-12-220000-00-00NoNoCurrent
63629-2952-26362929520220 CAPSULE in 1 BOTTLE (63629-2952-2) 20 capsule2021-12-220000-00-00NoNoCurrent
63629-2952-36362929520390 CAPSULE in 1 BOTTLE (63629-2952-3) 90 capsule2010-03-300000-00-00NoNoCurrent
63629-2952-46362929520460 CAPSULE in 1 BOTTLE (63629-2952-4) 60 capsule2010-03-300000-00-00NoNoCurrent
63629-2952-56362929520540 CAPSULE in 1 BOTTLE (63629-2952-5) 40 capsule2014-09-260000-00-00NoNoCurrent
63629-2952-66362929520618 CAPSULE in 1 BOTTLE (63629-2952-6) 18 capsule2021-12-220000-00-00NoNoCurrent