FDA.reportPublic FDA data

butalbital and acetaminophen

Product NDC
70010-054
11-digit product format
700100054
Labeler code
70010
Product ID
70010-054_5d4eb4aa-5315-85c1-e063-6394a90aef9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
butalbital and acetaminophen
Dosage form
CAPSULE
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA213115
Marketing category
ANDA
Marketing start
2020-01-20
Substance
BUTALBITAL; ACETAMINOPHEN
Active strength
50; 300 mg/1; mg/1
Pharmacologic classes
Barbiturate [EPC], Barbiturates [CS]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 45.

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
A213115-001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITAL300MG;50MGCAPSULE / ORALAA2019-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213115-001AA

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-11-14 07:37:172026-10A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22d4dbc9d85df4…
2026-10-15 13:18:302026-09A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22c2088c7a36db…
2026-09-14 22:38:342026-08A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-2284e616aacf4f…
2026-08-18 06:07:402026-07A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-224b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-2287673890dc5c…
2021-03-12 10:30 UTC2021-03A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-225aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-228869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22c0c555d07b60…
2019-12-14 00:12 UTC2019-12A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-223f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-226a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-221c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-229b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-223f0d92c62455…
2023-05-13 08:27 UTC2023-05A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22053a50430f4f…
2023-01-26 05:58 UTC2023-01A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-223bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-223a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213115-001BUTALBITAL AND ACETAMINOPHEN300MG;50MGCAPSULE / ORALAA2019-11-22e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-11-14 07:37:172026-10A213115-001AA1d4dbc9d85df4…
2026-10-15 13:18:302026-09A213115-001AA1c2088c7a36db…
2026-09-14 22:38:342026-08A213115-001AA184e616aacf4f…
2026-08-18 06:07:402026-07A213115-001AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A213115-001AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213115-001AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213115-001AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213115-001AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213115-001AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213115-001AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213115-001AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213115-001AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213115-001AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213115-001AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213115-001AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213115-001AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213115-001AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213115-001AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A213115-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A213115-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A213115-001AA14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A213115-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A213115-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A213115-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A213115-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A213115-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213115-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A213115-001AA13f01610625f2…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213115-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213115-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213115-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213115-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213115-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213115-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213115-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213115-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A213115-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A213115-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A213115-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A213115-001AA1e64feba35796…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2020-12-22 03:56 UTC2020-12A213115-001CGT2020-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A213115-001CGT2020-07-28c0c555d07b60…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
butalbital and acetaminophen
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BUTALBITAL50 mg/1
ACETAMINOPHEN300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1995136Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2091c292-b77b-4ce6-8bba-436c74eee3d7Available 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
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
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
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
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-054-01butalbital and acetaminophen100 in 1 BOTTLECAPSULE1003
70010-054-05butalbital and acetaminophen500 in 1 BOTTLECAPSULE5003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-054-01EA - Each70010-054b374db46-8979-43bc-9004-781e404eb0f812020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-054BUTALBITAL AND ACETAMINOPHEN CAPSULE [GRANULES PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 2 package rows20230215_2091c292-b77b-4ce6-8bba-436c74eee3d7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995136butalbital 50 MG / acetaminophen 300 MG Oral CapsulePSN2091c292-b77b-4ce6-8bba-436c74eee3d73
1995136acetaminophen 300 MG / butalbital 50 MG Oral CapsuleSCD2091c292-b77b-4ce6-8bba-436c74eee3d73
1995136APAP 300 MG / butalbital 50 MG Oral CapsuleSY2091c292-b77b-4ce6-8bba-436c74eee3d73
1995136butalbital 50 MG / acetaminophen 300 MG Oral CapsuleSY2091c292-b77b-4ce6-8bba-436c74eee3d73

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70010-054-0170010005401100 CAPSULE in 1 BOTTLE (70010-054-01) 100 capsule2020-01-200000-00-00NoNoCurrent
70010-054-0570010005405500 CAPSULE in 1 BOTTLE (70010-054-05) 500 capsule2020-01-200000-00-00NoNoCurrent