FDA.reportPublic FDA data

Butalbital, Acetaminophen, and Caffeine

Product NDC
0527-1695
11-digit product format
005271695
Labeler code
0527
Product ID
0527-1695_315b8ce7-eba3-4035-a5ab-4853ba0bb646
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA200243
Marketing category
ANDA
Marketing start
2012-09-13
Substance
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
Active strength
325; 50; 40 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [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, and Caffeine
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D, KHS0AZ4JVK, 3G6A5W338E
Rxcui238154

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
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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
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
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
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product 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
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
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d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0527-1695-012024-08-05C16284748780-11030e365-3c6c-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
0527-1695-052024-08-05C16284748780-11030e365-3c6c-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
0527-1695-012024-07-30C16284748780-11030e365-3c6c-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
0527-1695-052024-07-30C16284748780-11030e365-3c6c-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
0527-1695-012024-01-30C16284748780-11030e365-3c6c-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg
0527-1695-052024-01-30C16284748780-11030e365-3c6c-111a-e063-dadaa90a10e2Butalbital, Acetaminophen, and Caffeine Tablets, USP 50 mg/325 mg/40 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0527-1695-01Butalbital, Acetaminophen, and Caffeine100 in 1 BOTTLE, PLASTICTABLET10022
0527-1695-05Butalbital, Acetaminophen, and Caffeine500 in 1 BOTTLE, PLASTICTABLET50022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0527-1695-01EA - Each0527-1695d940c2e1-1cbf-45c9-878d-7d3a2e1239b512013-02-13
0527-1695-05EA - Each0527-1695693c2980-0e47-485b-abaa-880b2335459a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]12
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [RXCHANGE CO.]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [MEDSOURCE PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0527-1695BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [LANNETT COMPANY, INC.]22Current NDC, Legacy NDC, 2 package rows20240806_42594152-563e-4984-9901-d6ef3b8a6941.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN5b918d6b-94b0-4f9a-ab09-6a511b727de0101
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD5b918d6b-94b0-4f9a-ab09-6a511b727de0101
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY5b918d6b-94b0-4f9a-ab09-6a511b727de0101
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN42594152-563e-4984-9901-d6ef3b8a694122
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD42594152-563e-4984-9901-d6ef3b8a694122
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY42594152-563e-4984-9901-d6ef3b8a694122
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNbf333509-bf2b-43fa-9eb5-5193e442f32816
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDbf333509-bf2b-43fa-9eb5-5193e442f32816
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYbf333509-bf2b-43fa-9eb5-5193e442f32816
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN63e4e76a-7422-4c46-8aca-dc1a5d50f45a8
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN4ecb7bdc-4a43-7444-e054-00144ff88e888
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD63e4e76a-7422-4c46-8aca-dc1a5d50f45a8
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD4ecb7bdc-4a43-7444-e054-00144ff88e888
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY4ecb7bdc-4a43-7444-e054-00144ff88e888
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY63e4e76a-7422-4c46-8aca-dc1a5d50f45a8
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN0ca49c3c-f2cb-40e3-a7d5-5f48eca590167
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD0ca49c3c-f2cb-40e3-a7d5-5f48eca590167
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY0ca49c3c-f2cb-40e3-a7d5-5f48eca590167
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN65bc1e24-0409-45ad-8b57-afc73e2151146
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD65bc1e24-0409-45ad-8b57-afc73e2151146
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY65bc1e24-0409-45ad-8b57-afc73e2151146
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN7a2219a8-8aaf-44ad-9808-b67923df361a5
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD7a2219a8-8aaf-44ad-9808-b67923df361a5
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY7a2219a8-8aaf-44ad-9808-b67923df361a5
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNb7e8a3c5-9da8-4609-9907-7de9e3243f7d4
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDb7e8a3c5-9da8-4609-9907-7de9e3243f7d4
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYb7e8a3c5-9da8-4609-9907-7de9e3243f7d4
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNcff81c9b-47d9-4769-b42b-ad2724a7c80b3
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDcff81c9b-47d9-4769-b42b-ad2724a7c80b3
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYcff81c9b-47d9-4769-b42b-ad2724a7c80b3
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNf6dc9bbc-3331-b422-e053-6394a90af9a12
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNf36970e8-9905-43cb-8cfd-693545f183cf2
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN1d382246-ee7b-69cc-e054-00144ff8d46c2
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN85ce51e7-18c5-4ef2-8084-b1629dc322632
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD1d382246-ee7b-69cc-e054-00144ff8d46c2
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD85ce51e7-18c5-4ef2-8084-b1629dc322632
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDf36970e8-9905-43cb-8cfd-693545f183cf2
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDf6dc9bbc-3331-b422-e053-6394a90af9a12
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY1d382246-ee7b-69cc-e054-00144ff8d46c2
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYf36970e8-9905-43cb-8cfd-693545f183cf2
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYf6dc9bbc-3331-b422-e053-6394a90af9a12
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY85ce51e7-18c5-4ef2-8084-b1629dc322632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0527-1695-0100527169501100 TABLET in 1 BOTTLE, PLASTIC (0527-1695-01) 100 tablet2012-09-130000-00-00NoNoCurrent
0527-1695-0500527169505500 TABLET in 1 BOTTLE, PLASTIC (0527-1695-05) 500 tablet2012-09-130000-00-00NoNoCurrent