Butalbital, Acetaminophen and Caffeine

Product NDC
0143-1787
11-digit product format
001431787
Labeler code
0143
Product ID
0143-1787_fafdb910-e8f8-440d-b1f6-07ffaaae06d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen and Caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA089718
Marketing category
ANDA
Marketing start
1995-06-12
Marketing end
2021-03-31
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE
Active strength
50 mg/1; mg/1; mg/1
Pharmacologic classes
Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
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a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
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
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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
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182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product 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
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct 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
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-1787-01EA - Each0143-1787658db1a3-4346-4708-9396-d592dfaa45d812013-02-13
0143-1787-05EA - Each0143-1787736b385e-a140-4ae2-bdd0-eef145a9f99e12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]5
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
ASPIRINACTIVE INGREDIENTR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
ASPIRINACTIVE MOIETYR16CO5Y76EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
HYDROGENATED COTTONSEED OILINACTIVE INGREDIENTZ82Y2C65EABUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
TALCINACTIVE INGREDIENT7SEV7J4R1UBUTALBITAL, ASPIRIN AND CAFFEINE TABLET [H.J. HARKINS COMPANY]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
AcetaminophenACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
ButalbitalACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
CaffeineACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
AcetaminophenACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
ButalbitalACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338EACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
CaffeineACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
Colloidal Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4ACETAMINOPHEN, BUTALBITAL AND CAFFEINE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN69d4f4d9-2364-4cee-aa03-b223bec6de3117
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD69d4f4d9-2364-4cee-aa03-b223bec6de3117
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY69d4f4d9-2364-4cee-aa03-b223bec6de3117
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN41fbd224-1239-4d89-8e19-0a300cd66f388
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD41fbd224-1239-4d89-8e19-0a300cd66f388
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY41fbd224-1239-4d89-8e19-0a300cd66f388
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN098f223d-842b-46d3-ab8b-5a998571c4594
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD098f223d-842b-46d3-ab8b-5a998571c4594
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY098f223d-842b-46d3-ab8b-5a998571c4594
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN8c330933-ee51-4261-917e-155fddf1b7112
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD8c330933-ee51-4261-917e-155fddf1b7112
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY8c330933-ee51-4261-917e-155fddf1b7112
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN8e99c982-50ca-49d7-b80a-b60aa18401cb1
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNa04406b8-08fc-4d44-8b3c-63da3d7fb55b1
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD8e99c982-50ca-49d7-b80a-b60aa18401cb1
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDa04406b8-08fc-4d44-8b3c-63da3d7fb55b1
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY8e99c982-50ca-49d7-b80a-b60aa18401cb1
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYa04406b8-08fc-4d44-8b3c-63da3d7fb55b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-1787-0100143178701100 TABLET in 1 BOTTLE, PLASTIC (0143-1787-01) 100 tablet1995-06-122021-03-31NoNoCurrent
0143-1787-0500143178705500 TABLET in 1 BOTTLE, PLASTIC (0143-1787-05) 500 tablet1995-06-122021-03-31NoNoCurrent
0143-1787-10001431787101000 TABLET in 1 BOTTLE, PLASTIC (0143-1787-10) 1000 tablet1995-06-122021-03-31NoNoCurrent
0143-1787-300014317873030 TABLET in 1 BOTTLE, PLASTIC (0143-1787-30) 30 tablet1995-06-122021-03-31NoNoCurrent
0143-1787-500014317875050 TABLET in 1 BOTTLE, PLASTIC (0143-1787-50) 50 tablet1995-06-122021-03-31NoNoCurrent