Home NDC 66992-840-10 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 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204785-001 TREZIX ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 cb3db0bc1861…
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66992-840-10 Trezix 100 in 1 BOTTLE CAPSULE 100 12
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ACETAMINOPHEN ACTIVE INGREDIENT 362O9ITL9D TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 CAFFEINE ACTIVE INGREDIENT 3G6A5W338E TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 DIHYDROCODEINE BITARTRATE ACTIVE INGREDIENT 8LXS95BSA9 TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 ACETAMINOPHEN ACTIVE MOIETY 362O9ITL9D TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 CAFFEINE ACTIVE MOIETY 3G6A5W338E TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 DIHYDROCODEINE ACTIVE MOIETY N9I9HDB855 TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66992-840 TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [WRASER LLC] 12 Legacy NDC, 1 package rows 20210204_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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Trezix ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE Proficient Rx LP 45c3c2a1-6a89-471e-b6d4-5a4cd73b987a 2022-05-02 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 204785 application number: ANDA204785
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66992-840-10 66992084010 100 CAPSULE in 1 BOTTLE (66992-840-10) 100 capsule 2014-12-01 0000-00-00 No No Current