Oxycodone Hydrochloride

Product NDC
71335-9606
11-digit product format
713359606
Labeler code
71335
Product ID
71335-9606_0bd85212-b0e9-496c-9c56-bb275a9ddc1d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091490
Marketing category
ANDA
Marketing start
2014-09-08
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-9606DDiscontinued by firm2026-08-10
excluded packagepackage71335-960671335-9606-1DDiscontinued by firm2026-08-10
excluded packagepackage71335-960671335-9606-2DDiscontinued by firm2026-08-10
excluded packagepackage71335-960671335-9606-3DDiscontinued by firm2026-08-10
excluded packagepackage71335-960671335-9606-4DDiscontinued by firm2026-08-10

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 · 60 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 packagepackage71335-9606-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-9606-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-9606-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-9606-3d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-9606-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-9606-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-9606-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-9606-3f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-9606-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-9606-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-9606-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-9606-32ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-9606-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-9606-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-9606-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-9606-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-9606-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-9606-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-9606-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-9606-3cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-9606-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-9606-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-9606-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-9606-3cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-9606-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-9606-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-9606-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-9606-3302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-9606-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-9606-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-9606-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-9606-3ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-9606-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-9606-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-9606-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-9606-30efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-9606-4ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-9606-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-9606-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-9606-3ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-9606-4367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-9606-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-9606-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-9606-3367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-9606-4557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-9606-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-9606-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-9606-3557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A091490-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-09
A091490-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-09
A091490-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-09
A091490-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-09
A091490-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A091490-001AB
A091490-002AB
A091490-003AB
A091490-004AB
A091490-005AB

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 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2011-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2011-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2011-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2011-03-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2011-03-095bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A091490-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091490-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091490-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A091490-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A091490-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091490-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091490-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091490-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091490-005AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-004AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091490-005AB15bbf6a4d5a75…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackbb33bf7f-aa70-4e8a-91b2-4e0400dc328e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack0e4dd113-87ab-4a5d-846a-446db3cfd4692026-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERhodes Pharmaceuticals LLCa5162476-1217-41c0-bc7e-0a0f123f069f2026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack6de58d48-d6fc-46b4-ab7c-9ffdede855dc2026-04-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacka1e539ba-2cb5-4815-8c58-37abfd978fa52026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack7503ef9d-0fad-421f-951a-f35ab71f71c72026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack22f9eeaa-8aad-44f6-8258-e41edb60f8762026-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1a190488-3444-43b0-b9c8-45c1eb371aad2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.c10cc127-8756-4ddc-9f46-1e003ef271dc2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackd9841f2d-d182-4888-9a3c-68e1afb3e19c2024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ef58f422-682e-6896-e053-2a95a90a1f2d2024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1bcddbe1-c453-43ec-a822-9e993b885a5f2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091490
application number: ANDA091490

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-9606-17133596060130 TABLET in 1 BOTTLE, PLASTIC (71335-9606-1) 30 tablet2022-12-200000-00-00NoNoCurrent
71335-9606-27133596060260 TABLET in 1 BOTTLE, PLASTIC (71335-9606-2) 60 tablet2022-12-200000-00-00NoNoCurrent
71335-9606-37133596060390 TABLET in 1 BOTTLE, PLASTIC (71335-9606-3) 90 tablet2022-12-200000-00-00NoNoCurrent
71335-9606-471335960604120 TABLET in 1 BOTTLE, PLASTIC (71335-9606-4) 120 tablet2022-12-200000-00-00NoNoCurrent