FDA.reportPublic FDA data

Acetaminophen, Caffeine, Dihydrocodeine Bitartrate

Product NDC
42195-840
Requested package NDC
42195-840-10
11-digit product format
421950840
Labeler code
42195
Product ID
42195-840_8f97e457-8e1b-40fd-944c-f3806d9cc1d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetaminophen, Caffeine, Dihydrocodeine Bitartrate
Dosage form
CAPSULE
Route
ORAL
Labeler
Xspire Pharma, Llc
Application
ANDA204785
Marketing category
ANDA
Marketing start
2015-08-05
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

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 packagepackage42195-84042195-840-10IInactivated by FDA2026-07-31

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42195-840-102024-01-30C16284748780-1ba0f9c33-11f4-a910-e053-dadaa90a0b85Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only
42195-840-102021-02-02C16284748780-1ba0f9c33-11f4-a910-e053-dadaa90a0b85Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only
42195-840-102021-01-29C16284748780-1ba0f9c33-11f4-a910-e053-dadaa90a0b85Acetaminophen, Caffeine and Dihydrocodeine Bitartrate CIII 320.5 mg / 30 mg / 16 mg Capsules Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42195-840-10Acetaminophen, Caffeine, Dihydrocodeine Bitartrate100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42195-840-10EA - Each42195-840320f1f6a-f210-4691-8395-b5ecd10adaa312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
CAFFEINEACTIVE INGREDIENT3G6A5W338EACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
DIHYDROCODEINE BITARTRATEACTIVE INGREDIENT8LXS95BSA9ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
CAFFEINEACTIVE MOIETY3G6A5W338EACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
DIHYDROCODEINEACTIVE MOIETYN9I9HDB855ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
CROSPOVIDONE (15 MPA.S AT 5%)INACTIVE INGREDIENT68401960MKACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42195-840ACETAMINOPHEN, CAFFEINE, DIHYDROCODEINE BITARTRATE CAPSULE [XSPIRE PHARMA, LLC]3Legacy NDC, 1 package rows20210203_76e033b0-01c1-42df-bb64-f8ca401cfb6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1596108acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsulePSN76e033b0-01c1-42df-bb64-f8ca401cfb6b3
1596108acetaminophen 320.5 MG / caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsuleSCD76e033b0-01c1-42df-bb64-f8ca401cfb6b3
1596108APAP 320.5 MG / Caffeine 30 MG / dihydrocodeine bitartrate 16 MG Oral CapsuleSY76e033b0-01c1-42df-bb64-f8ca401cfb6b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42195-840-1042195084010100 CAPSULE in 1 BOTTLE (42195-840-10) 100 capsule2015-08-050000-00-00NoNoCurrent