FDA.reportPublic FDA data

Oxycodone Hydrochloride

Product NDC
0093-5731
11-digit product format
000935731
Labeler code
0093
Product ID
0093-5731_a5144031-83e4-4330-9c91-38b08b352141
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA022272
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-10-12
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct0093-5731DDiscontinued by firm2026-09-14
excluded packagepackage0093-57310093-5731-01DDiscontinued by firm2026-09-14

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 · 18 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 packagepackage0093-5731-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0093-5731-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0093-5731-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0093-5731-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0093-5731-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0093-5731-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0093-5731-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0093-5731-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0093-5731-010efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 301 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0584e616aacf4f…
2026-09-14 22:38:342026-08N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-0584e616aacf4f…
2026-08-18 06:07:402026-07N022272-001OXYCONTIN10MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022272-002OXYCONTIN15MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022272-003OXYCONTIN20MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022272-004OXYCONTIN30MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022272-005OXYCONTIN40MGTABLET, EXTENDED RELEASE / ORALRLD, RS2010-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022272-006OXYCONTIN60MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05caaa826d4ba7…
2026-08-18 06:07:402026-07N022272-007OXYCONTIN80MGTABLET, EXTENDED RELEASE / ORALRLD2010-04-05caaa826d4ba7…
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…

Observed Orange Book patent history#

Patent history page 1 of 139 · 5,544 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N022272-001113049082027-08-24Drug product2022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022272-001113049092027-08-24U-15562022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022272-001119640562027-08-24Drug product2024-04-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-001122460942027-08-24Drug product2025-03-1484e616aacf4f…
2026-09-14 22:38:342026-08N022272-001122801522027-08-24Drug product2025-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N022272-00188087412027-08-24U-15562014-08-1984e616aacf4f…
2026-09-14 22:38:342026-08N022272-00188949882027-08-24Drug product2014-11-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-00194923892027-08-24Drug product2016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00194923912027-08-24U-15562016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00194923922027-08-24Drug product2016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00194923932027-08-24U-15562016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00197639332027-08-24Drug product2017-09-1984e616aacf4f…
2026-09-14 22:38:342026-08N022272-00197704162027-08-24Drug product2017-09-2784e616aacf4f…
2026-09-14 22:38:342026-08N022272-00197758082027-08-24Drug product2017-10-0484e616aacf4f…
2026-09-14 22:38:342026-08N022272-00188949872030-03-29Drug product2014-11-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-002113049082027-08-24Drug product2022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022272-002113049092027-08-24U-15562022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022272-002119640562027-08-24Drug product2024-04-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-002122460942027-08-24Drug product2025-03-1484e616aacf4f…
2026-09-14 22:38:342026-08N022272-002122801522027-08-24Drug product2025-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N022272-00288087412027-08-24U-15562014-08-1984e616aacf4f…
2026-09-14 22:38:342026-08N022272-00288949882027-08-24Drug product2014-11-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-00294923892027-08-24Drug product2016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00294923912027-08-24U-15562016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00294923922027-08-24Drug product2016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00294923932027-08-24U-15562016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00297639332027-08-24Drug product2017-09-1984e616aacf4f…
2026-09-14 22:38:342026-08N022272-00297704162027-08-24Drug product2017-09-2784e616aacf4f…
2026-09-14 22:38:342026-08N022272-00297758082027-08-24Drug product2017-10-0484e616aacf4f…
2026-09-14 22:38:342026-08N022272-00288949872030-03-29Drug product2014-11-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-003113049082027-08-24Drug product2022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022272-003113049092027-08-24U-15562022-04-2184e616aacf4f…
2026-09-14 22:38:342026-08N022272-003119640562027-08-24Drug product2024-04-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-003122460942027-08-24Drug product2025-03-1484e616aacf4f…
2026-09-14 22:38:342026-08N022272-003122801522027-08-24Drug product2025-05-2284e616aacf4f…
2026-09-14 22:38:342026-08N022272-00388087412027-08-24U-15562014-08-1984e616aacf4f…
2026-09-14 22:38:342026-08N022272-00388949882027-08-24Drug product2014-11-2584e616aacf4f…
2026-09-14 22:38:342026-08N022272-00394923892027-08-24Drug product2016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00394923912027-08-24U-15562016-11-1684e616aacf4f…
2026-09-14 22:38:342026-08N022272-00394923922027-08-24Drug product2016-11-1684e616aacf4f…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
b8cd3792-f010-440e-ac63-7713119fde04Product name920220110
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
ac683e31-73f8-f1cd-ff51-87d7b0d20ab3Product name920190611
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
b7a189a6-82e9-f884-a16b-8cdc7e7d1556Product name620170913
5da64f4c-1e90-423d-af7a-5a52bb3e823eProduct name420170726
334cd9e0-ccc1-4fe7-b3a9-7d5942867ee6Product name120170628
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778Product name120161103
68d3ff71-7803-4cf4-ba84-71ce4712df22Product name120160620
07e5b999-fda7-79c9-8f77-8380537ade79Product name420160517
8a245632-e24f-4ccc-b671-995d89c96ebcProduct name120141203
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7fa873c5-fb27-7119-0a05-634ad477dea7Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
f46484d2-0de6-24f4-bf73-a8f2af6723efProduct name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5731-01EA - Each0093-5731308648e7-fae6-4053-95b9-3f8cf2f5b05612015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671POXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
INDIGOTINDISULFONATE SODIUMINACTIVE INGREDIENTD3741U8K7LOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPOXYCODONE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [TEVA PHARMACEUTICALS USA INC]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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1860157oxyCODONE HCl 10 MG 12HR Extended Release Oral Tablet, Abuse-DeterrentPSN603e7601-7e10-3821-e053-2a91aa0a22874
1860157Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral TabletSCD603e7601-7e10-3821-e053-2a91aa0a22874
1860157oxycodone HCl 10 MG 12 HR Extended Release Oral Tablet, Abuse-DeterrentSY603e7601-7e10-3821-e053-2a91aa0a22874

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5731-0100093573101100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0093-5731-01) 2015-10-120000-00-00NoNoCurrent