FDA.reportPublic FDA data

OxyContin

Product NDC
21695-951
11-digit product format
216950951
Labeler code
21695
Product ID
21695-951_a1b2e514-b75d-4f01-a9fd-83151f0ce813
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
NDA022272
Marketing category
NDA
Marketing start
2010-08-08
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
60 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct21695-951IInactivated by FDA2026-08-11
excluded packagepackage21695-95121695-951-60IInactivated by FDA2026-08-11

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage21695-951-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage21695-951-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage21695-951-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage21695-951-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage21695-951-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage21695-951-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage21695-951-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage21695-951-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage21695-951-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage21695-951-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage21695-951-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage21695-951-60557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage21695-951-608af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage21695-951-60834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage21695-951-601332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage21695-951-60fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage21695-951-6086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage21695-951-60bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage21695-951-608dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage21695-951-60e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage21695-951-609bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage21695-951-60110d247fa046…a55b01930146…

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
21695-951-602019-09-24C16284748780-1934fe258-4d1c-48b1-e053-8cdaa90a720aThese highlights do not include all the information needed to use OXYCONTIN ® safely and effectively. See full prescribing information for OXYCONTIN. OxyContin ® (oxycodone hydrochloride controlled-release) Tablets CII Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-951-60EA - Each21695-95121e42d0a-67cf-4e54-b92b-d733ea28e87e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
oxycodone hydrochlorideACTIVE INGREDIENTC1ENJ2TE6COXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
oxycodoneACTIVE MOIETYCD35PMG570OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
hypromellosesINACTIVE INGREDIENT3NXW29V3WOOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30OXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1AOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPOXYCONTIN (OXYCODONE HYDROCHLORIDE) TABLET, FILM COATED, EXTENDED RELEASE [REBEL DISTRIBUTORS CORP]1

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