FDA.reportPublic FDA data

Benzhydrocodone and Acetaminophen

Product NDC
10702-345
Requested package NDC
10702-345-01
11-digit product format
107020345
Labeler code
10702
Product ID
10702-345_c2b2ecba-e068-2abc-e053-2a95a90ae68c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Benzhydrocodone and Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
NDA208653
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-06-28
Marketing end
0000-00-00
Substance
BENZHYDROCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active strength
8 mg/1; mg/1
DEA schedule
CII
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 packagepackage10702-34510702-345-01DDiscontinued 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208653-001APADAZACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE325MG;EQ 6.12MG BASETABLET / ORALRLD2018-02-23
N208653-002APADAZACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE325MG;EQ 4.08MG BASETABLET / ORALRLD2019-01-04
N208653-003APADAZACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE325MG;EQ 8.16MG BASETABLET / ORALRLD2019-01-04

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208653-00187484132030-07-01Drug substance, Drug product2018-03-22
N208653-00188289782030-07-01Drug product2018-03-22
N208653-00191321252030-07-01U-2249Drug substance, Drug product2018-03-22
N208653-00195499232030-07-01Drug substance, Drug product2018-03-22
N208653-00184611372031-02-22Drug substance, Drug product2018-03-22
N208653-00287484132030-07-01Drug substance, Drug product2019-01-25
N208653-00288289782030-07-01Drug product2019-01-25
N208653-00291321252030-07-01U-2249Drug substance, Drug product2019-01-25
N208653-00295499232030-07-01Drug substance, Drug product2019-01-25
N208653-00284611372031-02-22Drug substance, Drug product2019-01-25
N208653-00387484132030-07-01Drug substance, Drug product2019-01-25
N208653-00388289782030-07-01Drug product2019-01-25
N208653-00391321252030-07-01U-2249Drug substance, Drug product2019-01-25
N208653-00395499232030-07-01Drug substance, Drug product2019-01-25
N208653-00384611372031-02-22Drug substance, Drug product2019-01-25

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 22:54:322026-06N208653-001APADAZ325MG;EQ 6.12MG BASETABLET / ORALRLD2018-02-23a50c72e98297…
2026-08-01 22:54:322026-06N208653-002APADAZ325MG;EQ 4.08MG BASETABLET / ORALRLD2019-01-04a50c72e98297…
2026-08-01 22:54:322026-06N208653-003APADAZ325MG;EQ 8.16MG BASETABLET / ORALRLD2019-01-04a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N208653-00187484132030-07-01Drug substance, Drug product2018-03-22a50c72e98297…
2026-08-01 22:54:322026-06N208653-00188289782030-07-01Drug product2018-03-22a50c72e98297…
2026-08-01 22:54:322026-06N208653-00191321252030-07-01U-2249Drug substance, Drug product2018-03-22a50c72e98297…
2026-08-01 22:54:322026-06N208653-00195499232030-07-01Drug substance, Drug product2018-03-22a50c72e98297…
2026-08-01 22:54:322026-06N208653-00184611372031-02-22Drug substance, Drug product2018-03-22a50c72e98297…
2026-08-01 22:54:322026-06N208653-00287484132030-07-01Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00288289782030-07-01Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00291321252030-07-01U-2249Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00295499232030-07-01Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00284611372031-02-22Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00387484132030-07-01Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00388289782030-07-01Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00391321252030-07-01U-2249Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00395499232030-07-01Drug substance, Drug product2019-01-25a50c72e98297…
2026-08-01 22:54:322026-06N208653-00384611372031-02-22Drug substance, Drug product2019-01-25a50c72e98297…

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
APADAZBENZHYDROCODONE AND ACETAMINOPHENZevra Therapeutics, Inc.0590d4e5-7107-4015-a6a8-deac14265aa22025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 208653
application number: NDA208653

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-345-012025-11-11C16284748780-11030e364-fc8f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BENZHYDROCODONE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for BENZHYDROCODONE AND ACETAMINOPHEN TABLETS. BENZHYDROCODONE AND ACETAMINOPHEN tablets, for oral use, CII Initial U.S. Approval: 1982
10702-345-012024-01-30C16284748780-11030e364-fc8f-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use BENZHYDROCODONE AND ACETAMINOPHEN TABLETS safely and effectively. See full prescribing information for BENZHYDROCODONE AND ACETAMINOPHEN TABLETS. BENZHYDROCODONE AND ACETAMINOPHEN tablets, for oral use, CII Initial U.S. Approval: 1982

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-345-01EA - Each10702-3453c8e82d3-4341-4beb-b6d6-8f0045eb2ab312019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-345BENZHYDROCODONE AND ACETAMINOPHEN TABLET [KVK-TECH, INC.]4Legacy NDC20210520_5e385b31-f3d4-4e30-a7d3-1461a838ed5f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10702-345-0110702034501100 TABLET in 1 BOTTLE, PLASTIC (10702-345-01) 100 tablet2019-06-280000-00-00NoNoCurrent