FDA.reportPublic FDA data

oxycodone hydrochloride

Product NDC
0781-5785
11-digit product format
007815785
Labeler code
0781
Product ID
0781-5785_2daac07a-7b11-4e90-bc56-20a4f54fbbf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sandoz Inc
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2014-10-08
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
80 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0781-5785DDiscontinued by firm2026-08-11
excluded packagepackage0781-57850781-5785-01DDiscontinued 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 · 26 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0781-5785-01DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0781-5785-01DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0781-5785-01DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0781-5785-01DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0781-5785-01DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0781-5785-01DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0781-5785-01DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0781-5785-01DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0781-5785-01DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0781-5785-01DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0781-5785-01DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0781-5785-01DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0781-5785-01IInactivated by FDA9bebd1f3094a…5416666fcb17…

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
0781-5785-012020-11-02C16284748780-19d75b9cf-e1d7-f424-e053-dadaa90a57ceThese 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
0781-5785-012020-01-31C16284748780-19d75b9cf-e1d7-f424-e053-dadaa90a57ceThese 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
0781-5785-01EA - Each0781-578589e14398-6b4e-4b26-bfd4-3bf642e7055d12014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxycodone hydrochlorideACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
oxycodoneACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
aluminum oxideINACTIVE INGREDIENTLMI26O6933OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
FD&C Blue NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
ferric oxide redINACTIVE INGREDIENT1K09F3G675OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
ferric oxide yellowINACTIVE INGREDIENTEX438O2MRTOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
magnesium stearateINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
polyethylene glycolsINACTIVE INGREDIENT3WJQ0SDW1AOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [SANDOZ INC]10

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