FDA.reportPublic FDA data

butalbital, acetaminophen and caffeine

Product NDC
46672-053
11-digit product format
466720053
Labeler code
46672
Product ID
46672-053_0e845d26-e49d-1fad-e063-6294a90ad864
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital, acetaminophen and caffeine
Dosage form
TABLET
Route
ORAL
Labeler
Mikart, LLC
Application
ANDA089175
Marketing category
ANDA
Marketing start
1987-01-21
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A089175-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-2187673890dc5c…
2021-03-12 10:30 UTC2021-03A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-215aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-218869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-213f01610625f2…
2019-09-15 20:21 UTC2019-09A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-211c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-219b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-213f0d92c62455…
2023-05-13 08:27 UTC2023-05A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21053a50430f4f…
2023-01-26 05:58 UTC2023-01A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-213bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-213a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089175-001BUTALBITAL, ACETAMINOPHEN AND CAFFEINE325MG;50MG;40MGTABLET / ORALAA1987-01-21cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A089175-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A089175-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A089175-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A089175-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A089175-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A089175-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A089175-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A089175-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A089175-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A089175-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A089175-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A089175-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A089175-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A089175-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A089175-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A089175-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A089175-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A089175-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A089175-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A089175-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A089175-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A089175-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A089175-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A089175-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A089175-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A089175-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A089175-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A089175-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A089175-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A089175-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A089175-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A089175-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A089175-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A089175-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A089175-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A089175-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A089175-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A089175-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A089175-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A089175-001AA1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
butalbital, acetaminophen and caffeine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL325 mg/1
ACETAMINOPHEN50 mg/1
CAFFEINE40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
KHS0AZ4JVKInternal UNII lookup
362O9ITL9DInternal UNII lookup
3G6A5W338EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
238154Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a26775c2-cafb-4b13-99ac-d4e8248265fbAvailable on FDA.report

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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46672-053-10butalbital, acetaminophen and caffeine100 in 1 BOTTLE, PLASTICTABLET1007
46672-053-50butalbital, acetaminophen and caffeine500 in 1 BOTTLE, PLASTICTABLET5007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46672-053-10EA - Each46672-0538004c669-0176-4f23-9af3-8819f62fe9da12012-07-24
46672-053-50EA - Each46672-05306e724b6-ef27-4351-a443-7e7d7fa8e13812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [DIRECT RX]5
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, INC.]4
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PREFERRED PHARMACEUTICALS, INC.]3
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL ACETAMINOPHEN AND CAFFEINE TABLET [NORTHWIND PHARMACEUTICALS]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [UNIT DOSE SERVICES]2
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APBUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46672-053BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET [MIKART, LLC]7Current NDC, Legacy NDC, 2 package rows20240110_a26775c2-cafb-4b13-99ac-d4e8248265fb.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEChartwell RX, LLC77776146-c6e6-478c-b30e-2b729e7584002025-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089175
application number: ANDA089175
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEMikart, LLCa26775c2-cafb-4b13-99ac-d4e8248265fb2024-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089175
application number: ANDA089175
ndc (product): 46672-053
butalbital, acetaminophen and caffeineBUTALBITAL, ACETAMINOPHEN AND CAFFEINEProficient Rx LP1bde13a5-cdd4-4bc2-8aeb-32e4dc1572932021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 089175
application number: ANDA089175

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNc0a97823-63d5-43fa-862f-2acce31856818
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDc0a97823-63d5-43fa-862f-2acce31856818
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYc0a97823-63d5-43fa-862f-2acce31856818
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSNa26775c2-cafb-4b13-99ac-d4e8248265fb7
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCDa26775c2-cafb-4b13-99ac-d4e8248265fb7
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSYa26775c2-cafb-4b13-99ac-d4e8248265fb7
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN71ab0446-3772-4680-93c5-8020d21dc15f5
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD71ab0446-3772-4680-93c5-8020d21dc15f5
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY71ab0446-3772-4680-93c5-8020d21dc15f5
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN1bde13a5-cdd4-4bc2-8aeb-32e4dc1572933
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD1bde13a5-cdd4-4bc2-8aeb-32e4dc1572933
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY1bde13a5-cdd4-4bc2-8aeb-32e4dc1572933
238154butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG Oral TabletPSN11690b28-5509-496a-9648-349158770ec22
238154acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSCD11690b28-5509-496a-9648-349158770ec22
238154APAP 325 MG / butalbital 50 MG / caffeine 40 MG Oral TabletSY11690b28-5509-496a-9648-349158770ec22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46672-053-1046672005310100 TABLET in 1 BOTTLE, PLASTIC (46672-053-10) 100 tablet1987-01-210000-00-00NoNoCurrent
46672-053-5046672005350500 TABLET in 1 BOTTLE, PLASTIC (46672-053-50) 500 tablet1987-01-210000-00-00NoNoCurrent