OXYCODONE HYDROCHLORIDE

Product NDC
71335-0115
11-digit product format
713350115
Labeler code
71335
Product ID
71335-0115_e0d1ec14-6a85-47d8-b964-4219bfdc9a27
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077290
Marketing category
ANDA
Marketing start
2012-12-26
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 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 · 10 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0115DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-3DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-4DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-5DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-6DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-7DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-8DDiscontinued by firm2026-08-17
excluded packagepackage71335-011571335-0115-9DDiscontinued by firm2026-08-17

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 2 · 120 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 packagepackage71335-0115-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0115-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0115-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0115-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0115-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0115-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-6cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-5cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-9cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-7cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0115-4cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077290-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08
A077290-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08
A077290-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08
A077290-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08
A077290-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08

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 6 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-08-18 06:07:402026-07A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-0803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077290-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077290-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077290-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077290-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2005-12-082680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077290-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2005-12-082680178bc6a6…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A077290-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077290-005AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A077290-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-003AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-004AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A077290-005AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A077290-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-003AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-004AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A077290-005AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A077290-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-003AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-004AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A077290-005AB1ea99ee380514…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0115-1EA - Each71335-0115f3e6acd9-9c60-41e6-8151-e8ec6332547c12018-05-09
71335-0115-2EA - Each71335-0115314ddc35-8671-4e9f-810b-ca4a75f968c112018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0115-17133501150130 TABLET in 1 BOTTLE (71335-0115-1) 30 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-27133501150260 TABLET in 1 BOTTLE (71335-0115-2) 60 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-37133501150390 TABLET in 1 BOTTLE (71335-0115-3) 90 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-47133501150456 TABLET in 1 BOTTLE (71335-0115-4) 56 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-571335011505100 TABLET in 1 BOTTLE (71335-0115-5) 100 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-671335011506120 TABLET in 1 BOTTLE (71335-0115-6) 120 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-77133501150750 TABLET in 1 BOTTLE (71335-0115-7) 50 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-87133501150840 TABLET in 1 BOTTLE (71335-0115-8) 40 tablet2015-02-020000-00-00NoNoCurrent
71335-0115-97133501150920 TABLET in 1 BOTTLE (71335-0115-9) 20 tablet2015-02-020000-00-00NoNoCurrent