FDA.reportPublic FDA data

OXYCODONE HCl

Product NDC
10702-803
Requested package NDC
10702-803-01
11-digit product format
107020803
Labeler code
10702
Product ID
10702-803_b48ac468-a5e7-4c8e-e053-2a95a90a5fcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HCl
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
KVK-Tech, Inc.
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-04-05
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage10702-80310702-803-01DDiscontinued by firm2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 7 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022272-001OXYCONTINOXYCODONE HYDROCHLORIDE10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-002OXYCONTINOXYCODONE HYDROCHLORIDE15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-003OXYCONTINOXYCODONE HYDROCHLORIDE20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-004OXYCONTINOXYCODONE HYDROCHLORIDE30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-005OXYCONTINOXYCODONE HYDROCHLORIDE40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05
N022272-006OXYCONTINOXYCODONE HYDROCHLORIDE60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05
N022272-007OXYCONTINOXYCODONE HYDROCHLORIDE80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05

Orange Book patents#

Current patent rows page 1 of 2 · 102 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022272-001113049082027-08-24Drug product2022-04-21
N022272-001113049092027-08-24U-15562022-04-21
N022272-001119640562027-08-24Drug product2024-04-25
N022272-001122460942027-08-24Drug product2025-03-14
N022272-001122801522027-08-24Drug product2025-05-22
N022272-00188087412027-08-24U-15562014-08-19
N022272-00188949882027-08-24Drug product2014-11-25
N022272-00194923892027-08-24Drug product2016-11-16
N022272-00194923912027-08-24U-15562016-11-16
N022272-00194923922027-08-24Drug product2016-11-16
N022272-00194923932027-08-24U-15562016-11-16
N022272-00197639332027-08-24Drug product2017-09-19
N022272-00197704162027-08-24Drug product2017-09-27
N022272-00197758082027-08-24Drug product2017-10-04
N022272-00188949872030-03-29Drug product2014-11-25
N022272-002113049082027-08-24Drug product2022-04-21
N022272-002113049092027-08-24U-15562022-04-21
N022272-002119640562027-08-24Drug product2024-04-25
N022272-002122460942027-08-24Drug product2025-03-14
N022272-002122801522027-08-24Drug product2025-05-22
N022272-00288087412027-08-24U-15562014-08-19
N022272-00288949882027-08-24Drug product2014-11-25
N022272-00294923892027-08-24Drug product2016-11-16
N022272-00294923912027-08-24U-15562016-11-16
N022272-00294923922027-08-24Drug product2016-11-16
N022272-00294923932027-08-24U-15562016-11-16
N022272-00297639332027-08-24Drug product2017-09-19
N022272-00297704162027-08-24Drug product2017-09-27
N022272-00297758082027-08-24Drug product2017-10-04
N022272-00288949872030-03-29Drug product2014-11-25
N022272-003113049082027-08-24Drug product2022-04-21
N022272-003113049092027-08-24U-15562022-04-21
N022272-003119640562027-08-24Drug product2024-04-25
N022272-003122460942027-08-24Drug product2025-03-14
N022272-003122801522027-08-24Drug product2025-05-22
N022272-00388087412027-08-24U-15562014-08-19
N022272-00388949882027-08-24Drug product2014-11-25
N022272-00394923892027-08-24Drug product2016-11-16
N022272-00394923912027-08-24U-15562016-11-16
N022272-00394923922027-08-24Drug product2016-11-16
N022272-00394923932027-08-24U-15562016-11-16
N022272-00397639332027-08-24Drug product2017-09-19
N022272-00397704162027-08-24Drug product2017-09-27
N022272-00397758082027-08-24Drug product2017-10-04
N022272-00388949872030-03-29Drug product2014-11-25
N022272-004113049082027-08-24Drug product2022-04-21
N022272-004113049092027-08-24U-15562022-04-21
N022272-004119640562027-08-24Drug product2024-04-25
N022272-004122460942027-08-24Drug product2025-03-14
N022272-004122801522027-08-24Drug product2025-05-22
N022272-00488087412027-08-24U-15562014-08-19
N022272-00488949882027-08-24Drug product2014-11-25
N022272-00494923892027-08-24Drug product2016-11-16
N022272-00494923912027-08-24U-15562016-11-16
N022272-00494923922027-08-24Drug product2016-11-16
N022272-00494923932027-08-24U-15562016-11-16
N022272-00497639332027-08-24Drug product2017-09-19
N022272-00497704162027-08-24Drug product2017-09-27
N022272-00497758082027-08-24Drug product2017-10-04
N022272-00488949872030-03-29Drug product2014-11-25
N022272-005113049082027-08-24Drug product2022-04-21
N022272-005113049092027-08-24U-15562022-04-21
N022272-005119640562027-08-24Drug product2024-04-25
N022272-005122460942027-08-24Drug product2025-03-14
N022272-005122801522027-08-24Drug product2025-05-22
N022272-00588087412027-08-24U-15562014-08-19
N022272-00588949882027-08-24Drug product2014-11-25
N022272-00594923892027-08-24Drug product2016-11-16
N022272-00594923912027-08-24U-15562016-11-16
N022272-00594923922027-08-24Drug product2016-11-16
N022272-00594923932027-08-24U-15562016-11-16
N022272-00597639332027-08-24Drug product2017-09-19
N022272-00597704162027-08-24Drug product2017-09-27
N022272-00597758082027-08-24Drug product2017-10-04
N022272-006113049082027-08-24Drug product2022-04-21
N022272-006113049092027-08-24U-15562022-04-21
N022272-006119640562027-08-24Drug product2024-04-25
N022272-006122460942027-08-24Drug product2025-03-14
N022272-006122801522027-08-24Drug product2025-05-22
N022272-00688087412027-08-24U-15562014-08-19

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.

Product history page 1 of 8 · 287 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-0503ed91905a0d…

Observed Orange Book patent history#

Patent history page 1 of 134 · 5,340 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022272-001113049082027-08-24Drug product2022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001113049092027-08-24U-15562022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001119640562027-08-24Drug product2024-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001122460942027-08-24Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-001122801522027-08-24Drug product2025-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00188087412027-08-24U-15562014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00188949882027-08-24Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923892027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923912027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923922027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00194923932027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00197639332027-08-24Drug product2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00197704162027-08-24Drug product2017-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00197758082027-08-24Drug product2017-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00188949872030-03-29Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002113049082027-08-24Drug product2022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002113049092027-08-24U-15562022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002119640562027-08-24Drug product2024-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002122460942027-08-24Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-002122801522027-08-24Drug product2025-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00288087412027-08-24U-15562014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00288949882027-08-24Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923892027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923912027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923922027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00294923932027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00297639332027-08-24Drug product2017-09-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00297704162027-08-24Drug product2017-09-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00297758082027-08-24Drug product2017-10-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00288949872030-03-29Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003113049082027-08-24Drug product2022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003113049092027-08-24U-15562022-04-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003119640562027-08-24Drug product2024-04-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003122460942027-08-24Drug product2025-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-003122801522027-08-24Drug product2025-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00388087412027-08-24U-15562014-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00388949882027-08-24Drug product2014-11-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00394923892027-08-24Drug product2016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00394923912027-08-24U-15562016-11-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022272-00394923922027-08-24Drug product2016-11-16011fe1cb6892…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10702-803-012025-06-17C16284748780-1f386c64a-25c4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXYCODONE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl EXTENDED-RELEASE TABLETS. OXYCODONE HCl EXTENDED-RELEASE TABLETS, for oral use, CII Initial U.S. Approval: 1950
10702-803-012023-01-30C16284748780-1f386c64a-25c4-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use OXYCODONE HCl EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl EXTENDED-RELEASE TABLETS. OXYCODONE HCl EXTENDED-RELEASE TABLETS, for oral use, CII Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10702-803-01EA - Each10702-8031e185e6f-e0b5-44f2-b150-dd2a03480fab12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10702-803OXYCODONE HCL TABLET, FILM COATED, EXTENDED RELEASE [KVK-TECH, INC.]3Legacy NDC20201121_c5b52ff1-21a6-4d28-9982-55b4ac195fac.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OxyContinOXYCODONE HYDROCHLORIDEKnoa Pharma LLCbfdfe235-d717-4855-a3c8-a13d26dadede2026-06-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022272
application number: NDA022272
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmneal Pharmaceuticals of New York LLCc2c57ae7-86b9-47bb-a31b-ed1c4327ce7f2026-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022272
application number: NDA022272

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
10702-803-0110702080301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (10702-803-01) 2019-04-050000-00-00NoNoCurrent