Home NDC 63187-705-00 Trezix
Product NDC 63187-705
Requested package NDC 63187-705-00
11-digit product format 631870705
Labeler code 63187
Product ID 63187-705_cf14c5ce-0aa3-4511-9db0-7d5aa995f04d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acetaminophen, caffeine, dihydrocodeine bitartrate
Dosage form CAPSULE
Route ORAL
Labeler Proficient Rx LP
Application ANDA204785
Marketing category ANDA
Marketing start 2014-12-01
Substance ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
Active strength 320.5; 30; 16 mg/1; mg/1; mg/1
Pharmacologic classes Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Full Opioid Agonists [MoA], Methylxanthine [EPC], Opioid Agonist [EPC], Xanthines [CS]
DEA schedule CIII
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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…
Additional Listing Data#
Finished product Yes
Brand name base Trezix
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 320.5 mg/1 CAFFEINE 30 mg/1 DIHYDROCODEINE BITARTRATE 16 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 3G6A5W338E Internal UNII lookup 8LXS95BSA9 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1190201 Internal RxNorm lookup 1596108 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-705 TREZIX (ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE) CAPSULE [PROFICIENT RX LP] 6 Current NDC, Legacy NDC, 5 package rows 20220525_45c3c2a1-6a89-471e-b6d4-5a4cd73b987a.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.
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 63187-705-00 63187070500 100 CAPSULE in 1 BOTTLE (63187-705-00) 100 capsule 2016-06-01 0000-00-00 No No Current