FDA.reportPublic FDA data

Trezix

Product NDC
63629-5637
Requested package NDC
63629-5637-3
11-digit product format
636295637
Labeler code
63629
Product ID
63629-5637_f90f87cb-77ad-45f4-8b59-09459090d988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaminophen, caffeine, dihydrocodeine bitartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
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
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-563763629-5637-3DDiscontinued by firm2026-07-31

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A204785-001TREZIX320.5MG;30MG;16MGCAPSULE / ORAL2014-11-26a50c72e98297…

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63629-5637-12020-10-16C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-22020-10-16C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-32020-10-16C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-42020-10-16C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-12020-01-31C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-22020-01-31C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-32020-01-31C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules
63629-5637-42020-01-31C16284748780-19d75b9d0-e2ea-f424-e053-dadaa90a57ceTREZIX™ Capsules

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-5637-1EA - Each63629-56372e8991df-d990-4808-acdb-6376e94a137c12017-03-06
63629-5637-2EA - Each63629-563716e143b5-6fa3-48cd-8432-c73c2abb262e12017-03-06
63629-5637-3EA - Each63629-563760e55cb6-a33a-4b9d-ab14-b6a4b3ea7e3312017-03-06
63629-5637-4EA - Each63629-563748da6532-6f8f-4ab6-96b8-eb975b5f239f12017-03-06

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-5637-36362956370390 CAPSULE in 1 BOTTLE (63629-5637-3) 90 capsule2015-07-100000-00-00NoNoCurrent