Trezix

Product NDC
66992-840
Requested package NDC
66992-840-10
11-digit product format
669920840
Labeler code
66992
Product ID
66992-840_34095d36-7525-4953-bce7-d86031545d5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen, caffeine, dihydrocodeine bitartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Wraser Llc
Application
ANDA204785
Marketing category
ANDA
Marketing start
2014-12-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Active strength
321 mg/1; mg/1; mg/1
Pharmacologic classes
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
2022-12-31
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 packagepackage66992-84066992-840-10IInactivated by FDA2026-08-03

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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
A204785-001TREZIXACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26

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 UTC2026-02A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26cb3db0bc1861…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66992-840-102024-01-30C16284748780-1ba0f9c33-0ffd-a910-e053-dadaa90a0b85TREZIX™ Capsules
66992-840-102021-02-02C16284748780-1ba0f9c33-0ffd-a910-e053-dadaa90a0b85TREZIX™ Capsules
66992-840-102021-01-29C16284748780-1ba0f9c33-0ffd-a910-e053-dadaa90a0b85TREZIX™ Capsules

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66992-840-10Trezix100 in 1 BOTTLECAPSULE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66992-840-10EA - Each66992-8400b6251be-5b91-48cf-8a9d-f682c949927b12015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DTREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338ETREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
DIHYDROCODEINE BITARTRATEACTIVE INGREDIENT8LXS95BSA9TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DTREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338ETREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
DIHYDROCODEINEACTIVE MOIETYN9I9HDB855TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ETREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APTREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66992-840TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC]12Legacy NDC, 1 package rows20210204_a519a201-bcfd-4029-9bdf-fc3e03f975ac.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrezixACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATEProficient Rx LP45c3c2a1-6a89-471e-b6d4-5a4cd73b987a2022-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204785
application number: ANDA204785

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596108acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsulePSNa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1190201TREZIX 16 MG / 320.5 MG / 30 MG Oral CapsulePSNa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1190201acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SBDa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1596108acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsuleSCDa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1596108APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsuleSYa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1190201APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SYa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1190201Trezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral CapsuleSYa519a201-bcfd-4029-9bdf-fc3e03f975ac12
1596108acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsulePSN45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6
1190201TREZIX 16 MG / 320.5 MG / 30 MG Oral CapsulePSN45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6
1190201acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SBD45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6
1596108acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsuleSCD45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6
1596108APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsuleSY45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6
1190201APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral Capsule [Trezix]SY45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6
1190201Trezix (acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG) Oral CapsuleSY45c3c2a1-6a89-471e-b6d4-5a4cd73b987a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66992-840-1066992084010100 CAPSULE in 1 BOTTLE (66992-840-10) 100 capsule2014-12-010000-00-00NoNoCurrent