Home NDC 63187-705-72 Trezix
Product NDC 63187-705
Requested package NDC 63187-705-72
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.
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.
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
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 63187-705-72 63187070572 120 CAPSULE in 1 BOTTLE (63187-705-72) 120 capsule 2018-08-01 0000-00-00 No No Current