FDA.reportPublic FDA data

Ascomp with Codeine

Product NDC
51991-074
11-digit product format
519910074
Labeler code
51991
Product ID
51991-074_a41a61f0-e530-4fb5-8198-bdc866219e33
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Aspirin, Caffeine and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ascomp with Codeine
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, 994239

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-074-01Ascomp with Codeine100 in 1 BOTTLE, PLASTICCAPSULE10013
51991-074-05Ascomp with Codeine500 in 1 BOTTLE, PLASTICCAPSULE50013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-074-01EA - Each51991-074814b4cc4-9789-4bc7-9f3b-8557e2e9be5812012-07-24
51991-074-05EA - Each51991-0748dfd860d-f91a-4e0f-868e-f7fda824113412012-07-24

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
AspirinACTIVE INGREDIENTR16CO5Y76EASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
ButalbitalACTIVE INGREDIENTKHS0AZ4JVKASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
CaffeineACTIVE INGREDIENT3G6A5W338EASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
Codeine PhosphateACTIVE INGREDIENTGSL05Y1MN6ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
AspirinACTIVE MOIETYR16CO5Y76EASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
ButalbitalACTIVE MOIETYKHS0AZ4JVKASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
CaffeineACTIVE MOIETY3G6A5W338EASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
CodeineACTIVE MOIETYQ830PW7520ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
Cellulose, MicrocrystallineINACTIVE INGREDIENTOP1R32D61UASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
D&C Red No. 28INACTIVE INGREDIENT767IP0Y5NHASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOAASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
GelatinINACTIVE INGREDIENT2G86QN327LASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
Starch, CornINACTIVE INGREDIENTO8232NY3SJASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
TalcINACTIVE INGREDIENT7SEV7J4R1UASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-074ASCOMP WITH CODEINE (BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE) CAPSULE [BRECKENRIDGE PHARMACEUTICAL, INC.]12Current NDC, Legacy NDC, 2 package rows20250115_243a6aea-0f48-42a9-a85e-ff247ab94336.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
994239Ascomp with Codeine 50 MG / 325 MG / 40 MG / 30 MG Oral CapsulePSN243a6aea-0f48-42a9-a85e-ff247ab9433613
994237butalbital 50 MG / aspirin 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN243a6aea-0f48-42a9-a85e-ff247ab9433613
994239aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral Capsule [Ascomp]SBD243a6aea-0f48-42a9-a85e-ff247ab9433613
994237aspirin 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD243a6aea-0f48-42a9-a85e-ff247ab9433613
994237ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY243a6aea-0f48-42a9-a85e-ff247ab9433613
994239ASA 325 MG / butalbital 50 MG / Caffeine 40 MG / Codeine Phosphate 30 MG Oral Capsule [Ascomp]SY243a6aea-0f48-42a9-a85e-ff247ab9433613
994239Ascomp with Codeine (ASA 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG) Oral CapsuleSY243a6aea-0f48-42a9-a85e-ff247ab9433613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-074-0151991007401100 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-01) 100 capsule2009-05-010000-00-00NoNoCurrent
51991-074-0551991007405500 CAPSULE in 1 BOTTLE, PLASTIC (51991-074-05) 500 capsule2009-05-010000-00-00NoNoCurrent