Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate

Product NDC
63629-3152
Requested package NDC
63629-3152-2
11-digit product format
636293152
Labeler code
63629
Product ID
63629-3152_3f0c092b-08db-4e8f-136a-456e0e7bec14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA020232
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2003-09-18
Marketing end
0000-00-00
Substance
CODEINE PHOSPHATE; BUTALBITAL; CAFFEINE; ACETAMINOPHEN
Active strength
30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC],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
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-315263629-3152-2DDiscontinued by firm2026-08-11

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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
N020232-001FIORICET W/ CODEINEACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N020232-001AB

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 UTC2026-02N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-304b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-3074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-3087673890dc5c…
2021-03-12 10:30 UTC2021-03N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-305aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-308869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-303f01610625f2…
2019-09-15 20:21 UTC2019-09N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30b00525d2431f…
2019-07-19 19:46 UTC2019-07N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-306a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-301c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-309b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-303f0d92c62455…
2023-05-13 08:27 UTC2023-05N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30053a50430f4f…
2023-01-26 05:58 UTC2023-01N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-303bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-303a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020232-001FIORICET W/ CODEINE325MG;50MG;40MG;30MGCAPSULE / ORALABRLD, RS1992-07-30cb3db0bc1861…

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 UTC2026-02N020232-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020232-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020232-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020232-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020232-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020232-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020232-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020232-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020232-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020232-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020232-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020232-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020232-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020232-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020232-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020232-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020232-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020232-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020232-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020232-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020232-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020232-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020232-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020232-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020232-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020232-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020232-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020232-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020232-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020232-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020232-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020232-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020232-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020232-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020232-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020232-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020232-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020232-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020232-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020232-001AB1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-3152-12020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-22020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-32020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-42020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-52020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-62020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-72020-10-16These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-12020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-22020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-32020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-42020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-52020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-62020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992
63629-3152-72020-01-31These highlights do not include all the information needed to use Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules safely and effectively. See full prescribing information for Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules. Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules for oral use, CIII Initial U.S. Approval: 1992

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-3152-1EA - Each63629-3152e331ba7e-bfad-42b3-9f4a-2aa17399942312012-07-24
63629-3152-2EA - Each63629-315256166d11-c02a-4d1f-86d9-48bdff09bb3312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
BUTALBITALACTIVE INGREDIENTKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CAFFEINEACTIVE INGREDIENT3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CODEINE PHOSPHATEACTIVE INGREDIENTGSL05Y1MN6BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
BUTALBITALACTIVE MOIETYKHS0AZ4JVKBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CAFFEINEACTIVE MOIETY3G6A5W338EBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
CODEINE ANHYDROUSACTIVE MOIETYUX6OWY2V7JBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
D&C RED NO. 7INACTIVE INGREDIENTECW0LZ41X8BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
GELATININACTIVE INGREDIENT2G86QN327LBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4BUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATE CAPSULE [BRYANT RANCH PREPACK]2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Butalbital, Acetaminophen, Caffeine, and Codeine PhosphateBUTALBITAL, ACETAMINOPHEN, CAFFEINE, AND CODEINE PHOSPHATEActavis Pharma, Inc.a58819b8-a52c-44a7-9ab0-c74480d985062026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 020232
application number: NDA020232

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-3152-26362931520290 CAPSULE in 1 BOTTLE (63629-3152-2) 90 capsule2006-10-190000-00-00NoNoCurrent