FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine and Codeine Phosphate

Product NDC
71335-0194
11-digit product format
713350194
Labeler code
71335
Product ID
71335-0194_ab86ae24-3103-4976-bd9d-8c90b76c5f29
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Butalbital, Acetaminophen, Caffeine and Codeine Phosphate
Listing expiration
2027-12-31

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
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
377068df-225f-7318-a910-a1987cdfa361Product name320170608
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
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
53855190-7124-8179-f018-e792f7c27f28Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0194-1Butalbital, Acetaminophen, Caffeine and Codeine Phosphate20 in 1 BOTTLECAPSULE2010
71335-0194-2Butalbital, Acetaminophen, Caffeine and Codeine Phosphate90 in 1 BOTTLECAPSULE9010
71335-0194-3Butalbital, Acetaminophen, Caffeine and Codeine Phosphate30 in 1 BOTTLECAPSULE3010
71335-0194-4Butalbital, Acetaminophen, Caffeine and Codeine Phosphate60 in 1 BOTTLECAPSULE6010
71335-0194-5Butalbital, Acetaminophen, Caffeine and Codeine Phosphate100 in 1 BOTTLECAPSULE10010
71335-0194-6Butalbital, Acetaminophen, Caffeine and Codeine Phosphate15 in 1 BOTTLECAPSULE1510
71335-0194-7Butalbital, Acetaminophen, Caffeine and Codeine Phosphate18 in 1 BOTTLECAPSULE1810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0194-1EA - Each71335-0194e518e518-b24c-48a4-bf40-52261c5ee32e12020-09-14
71335-0194-2EA - Each71335-0194b45e0420-0578-4c3c-9ba9-50f892763c5112020-09-14
71335-0194-3EA - Each71335-0194fd05fe71-d226-4f73-8143-ed1a87836adf12020-09-14
71335-0194-4EA - Each71335-019422dc70e6-bd4f-47ac-a20a-487f3cc8be1512020-09-14
71335-0194-5EA - Each71335-01946b03c064-c6bc-4e06-a91f-5a18426d67c412020-09-14
71335-0194-6EA - Each71335-019455bf233d-dd26-4474-a177-07bb42dcac0312020-09-14
71335-0194-7EA - Each71335-0194e49832b1-d626-4755-8d7e-8680caa32e6712020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0194BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 7 package rows20240510_15a34df5-e48f-4570-9232-80e4093c4624.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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0194-17133501940120 CAPSULE in 1 BOTTLE (71335-0194-1) 20 capsule2021-12-270000-00-00NoNoCurrent
71335-0194-27133501940290 CAPSULE in 1 BOTTLE (71335-0194-2) 90 capsule2019-08-300000-00-00NoNoCurrent
71335-0194-37133501940330 CAPSULE in 1 BOTTLE (71335-0194-3) 30 capsule2021-12-270000-00-00NoNoCurrent
71335-0194-47133501940460 CAPSULE in 1 BOTTLE (71335-0194-4) 60 capsule2021-12-130000-00-00NoNoCurrent
71335-0194-571335019405100 CAPSULE in 1 BOTTLE (71335-0194-5) 100 capsule2021-12-270000-00-00NoNoCurrent
71335-0194-67133501940615 CAPSULE in 1 BOTTLE (71335-0194-6) 15 capsule2021-12-270000-00-00NoNoCurrent
71335-0194-77133501940718 CAPSULE in 1 BOTTLE (71335-0194-7) 18 capsule2021-12-270000-00-00NoNoCurrent