Home NDC 66992-840 Trezix
Product NDC 66992-840
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 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.
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 2026-08-01 22:54:32 2026-06 A204785-001 TREZIX 320.5MG;30MG;16MG CAPSULE / ORAL 2014-11-26 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 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
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