FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine

Product NDC
69367-203
11-digit product format
693670203
Labeler code
69367
Product ID
69367-203_23d91a38-6b01-4d89-a454-45a9cac1a294
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA209587
Marketing category
ANDA
Marketing start
2019-03-05
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, 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
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20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
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92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
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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
b8e0daf1-fb81-290b-c0bf-873be19ef775Product 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
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-203-01Butalbital, Acetaminophen, Caffeine100 in 1 BOTTLETABLET1008
69367-203-05Butalbital, Acetaminophen, Caffeine500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-203-01EA - Each69367-20388d12b6d-5662-476b-a61c-628e217a0d1f12019-05-02
69367-203-05EA - Each69367-203100815e0-5fd6-48d8-a247-d0b8aab0eee812019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-203BUTALBITAL, ACETAMINOPHEN, CAFFEINE (BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE) TABLET [WESTMINSTER PHARMACEUTICALS, LLC]8Current NDC, Legacy NDC, 2 package rows20220910_1c0511d0-fe63-45c6-8da2-6ceeb56edb17.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNe2978345-826a-47d2-acf3-feb6afb1967e106
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDe2978345-826a-47d2-acf3-feb6afb1967e106
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYe2978345-826a-47d2-acf3-feb6afb1967e106
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN90e166ac-8789-4e7a-b5bb-37c475e3a5b0102
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD90e166ac-8789-4e7a-b5bb-37c475e3a5b0102
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY90e166ac-8789-4e7a-b5bb-37c475e3a5b0102
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN1c0511d0-fe63-45c6-8da2-6ceeb56edb178
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD1c0511d0-fe63-45c6-8da2-6ceeb56edb178
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY1c0511d0-fe63-45c6-8da2-6ceeb56edb178
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNb121190e-db2a-43bb-a57d-b6683a9e20595
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDb121190e-db2a-43bb-a57d-b6683a9e20595
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYb121190e-db2a-43bb-a57d-b6683a9e20595
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNf822c103-b678-4e76-8174-33b94421dd1e4
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN2abb9915-edb2-6218-e063-6394a90ad4624
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNd860af16-fab4-4263-9e66-a648d5e81dab4
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDf822c103-b678-4e76-8174-33b94421dd1e4
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD2abb9915-edb2-6218-e063-6394a90ad4624
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDd860af16-fab4-4263-9e66-a648d5e81dab4
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYd860af16-fab4-4263-9e66-a648d5e81dab4
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYf822c103-b678-4e76-8174-33b94421dd1e4
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY2abb9915-edb2-6218-e063-6394a90ad4624
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN3cf799b4-c785-4ae2-908b-c42e426733dc3
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNbd5d031e-e5e2-1671-e053-2995a90a5d5a3
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNdc2bb7fc-1722-4865-a02c-be5e5c2115053
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNe5fbd6b8-85e7-8847-e053-2a95a90a52ed3
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDbd5d031e-e5e2-1671-e053-2995a90a5d5a3
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDdc2bb7fc-1722-4865-a02c-be5e5c2115053
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDe5fbd6b8-85e7-8847-e053-2a95a90a52ed3
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD3cf799b4-c785-4ae2-908b-c42e426733dc3
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYdc2bb7fc-1722-4865-a02c-be5e5c2115053
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY3cf799b4-c785-4ae2-908b-c42e426733dc3
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYe5fbd6b8-85e7-8847-e053-2a95a90a52ed3
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYbd5d031e-e5e2-1671-e053-2995a90a5d5a3
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNcce09e09-158f-4927-8a3e-4ec9334f0b7a2
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDcce09e09-158f-4927-8a3e-4ec9334f0b7a2
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYcce09e09-158f-4927-8a3e-4ec9334f0b7a2
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN4871c36f-229b-4c12-e063-6394a90a028e1
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD4871c36f-229b-4c12-e063-6394a90a028e1
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY4871c36f-229b-4c12-e063-6394a90a028e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69367-203-0169367020301100 TABLET in 1 BOTTLE (69367-203-01) 100 tablet2019-03-050000-00-00NoNoCurrent
69367-203-0569367020305500 TABLET in 1 BOTTLE (69367-203-05) 500 tablet2019-03-050000-00-00NoNoCurrent