FDA.reportPublic FDA data

Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Product NDC
71335-0653
11-digit product format
713350653
Labeler code
71335
Product ID
71335-0653_a29db87b-3f50-40ca-a5ab-406028ff19f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075929
Marketing category
ANDA
Marketing start
2002-04-22
Marketing end
0000-00-00
Substance
BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE PHOSPHATE
Active strength
50 mg/1; 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],Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 8 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0653DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-1DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-2DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-3DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-4DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-5DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-6DDiscontinued by firm2026-10-05
excluded packagepackage71335-065371335-0653-7DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 16 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0653-7d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0653-7f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A075929-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2002-04-22

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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A075929-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2002-04-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075929-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALAB2002-04-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A075929-001BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORAL2002-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-05-31 18:47 UTC2024-05A075929-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075929-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075929-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075929-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075929-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075929-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075929-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075929-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A075929-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075929-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075929-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075929-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A075929-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A075929-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075929-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075929-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075929-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075929-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075929-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075929-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075929-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A075929-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A075929-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075929-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075929-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A075929-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A075929-001AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

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

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
09d8330d-4fec-be98-3a66-f985140646b2Product name220210513
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
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730
e9576821-a971-5261-628e-82ad9e10acdbProduct name220150121
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
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2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct 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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c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
ce055423-1d7f-3c41-dff1-83660fa8cd96Product 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
71335-0653-1Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate20 in 1 BOTTLECAPSULE204
71335-0653-2Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate90 in 1 BOTTLECAPSULE904
71335-0653-3Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate30 in 1 BOTTLECAPSULE304
71335-0653-4Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate60 in 1 BOTTLECAPSULE604
71335-0653-5Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate100 in 1 BOTTLECAPSULE1004
71335-0653-6Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate15 in 1 BOTTLECAPSULE154
71335-0653-7Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate18 in 1 BOTTLECAPSULE184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0653BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]4Legacy NDC, 7 package rows20200924_00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
993943butalbital 50 MG / acetaminophen 325 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsulePSN00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe4
993943acetaminophen 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSCD00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe4
993943APAP 325 MG / butalbital 50 MG / caffeine 40 MG / codeine phosphate 30 MG Oral CapsuleSY00431d9b-fe0b-4aab-9d18-ac6ee6b9d6fe4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0653-17133506530120 CAPSULE in 1 BOTTLE (71335-0653-1) 20 capsule2018-01-250000-00-00NoNoCurrent
71335-0653-27133506530290 CAPSULE in 1 BOTTLE (71335-0653-2) 90 capsule2018-01-250000-00-00NoNoCurrent
71335-0653-37133506530330 CAPSULE in 1 BOTTLE (71335-0653-3) 30 capsule2018-01-250000-00-00NoNoCurrent
71335-0653-47133506530460 CAPSULE in 1 BOTTLE (71335-0653-4) 60 capsule2018-01-250000-00-00NoNoCurrent
71335-0653-571335065305100 CAPSULE in 1 BOTTLE (71335-0653-5) 100 capsule2018-01-250000-00-00NoNoCurrent
71335-0653-67133506530615 CAPSULE in 1 BOTTLE (71335-0653-6) 15 capsule2018-01-250000-00-00NoNoCurrent
71335-0653-77133506530718 CAPSULE in 1 BOTTLE (71335-0653-7) 18 capsule2018-01-250000-00-00NoNoCurrent