OXYCODONE HYDROCHLORIDE

Product NDC
63629-4606
Requested package NDC
63629-4606-5
11-digit product format
636294606
Labeler code
63629
Product ID
63629-4606_e0424639-94d0-41dd-b656-4cdb08b310da
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
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63629-460663629-4606-5DDiscontinued 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 1 · 13 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 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…

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…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-4606-12020-10-16These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-22020-10-16These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-32020-10-16These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-42020-10-16These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-52020-10-16These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-62020-10-16These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-12020-01-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-22020-01-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-32020-01-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-42020-01-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-52020-01-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950
63629-4606-62020-01-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS CII Initial U.S. Approval: 1950

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4606-1EA - Each63629-46061a58316b-a7ce-4512-9e20-98e1bf6ba5da12023-09-05
63629-4606-2EA - Each63629-4606725875c1-2e3b-499a-9776-c2705636de8912016-05-16
63629-4606-3EA - Each63629-4606de66e426-9d7c-4b40-a8b7-3fc7afecb21e12016-05-16
63629-4606-4EA - Each63629-46062ef72a84-1890-45ea-96a2-539e3a9eb1e712023-09-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]1000

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4606-56362946060540 TABLET in 1 BOTTLE (63629-4606-5) 40 tablet2021-12-220000-00-00NoNoCurrent