Oxycodone Hydrochloride

Product NDC
50383-961
11-digit product format
503830961
Labeler code
50383
Product ID
50383-961_a32f4de0-1ae9-4caf-b9cb-e63340c43f92
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Akorn
Application
ANDA208817
Marketing category
ANDA
Marketing start
2017-08-10
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/5mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50383-961DDiscontinued by firm2026-08-03
excluded packagepackage50383-96150383-961-06DDiscontinued by firm2026-08-03
excluded packagepackage50383-96150383-961-34DDiscontinued by firm2026-08-03

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-961-34DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50383-961-06DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-961-34IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50383-961-06DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-961-34IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage50383-961-06DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-961-34IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage50383-961-06DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-961-34IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage50383-961-06DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-961-34IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage50383-961-06DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-961-34IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage50383-961-06DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-961-34IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage50383-961-06DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-961-34IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50383-961-06DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-961-34IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage50383-961-06DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-961-34IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage50383-961-06DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-961-34IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50383-961-06DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50383-961-34IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50383-961-34IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50383-961-34IInactivated by FDA1332a3947898…d4bfe170f9cd…

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A208817-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-1031067a03dcf5…
2025-08-23 18:47 UTC2025-08A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-106a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-1003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-102680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-105bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-1079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-10301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-101e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2017-08-108072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-1087673890dc5c…
2021-03-12 10:30 UTC2021-03A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-103f01610625f2…
2019-09-15 20:21 UTC2019-09A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10b00525d2431f…
2019-07-19 19:46 UTC2019-07A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-106a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-101c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-109b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-103f0d92c62455…
2023-05-13 08:27 UTC2023-05A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10053a50430f4f…
2023-01-26 05:58 UTC2023-01A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-103bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-103a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208817-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2017-08-10cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208817-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208817-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208817-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208817-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208817-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208817-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208817-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A208817-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208817-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208817-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208817-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A208817-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208817-001AA1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208817-001AA16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208817-001AA11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208817-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208817-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208817-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208817-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208817-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05A208817-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01A208817-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208817-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208817-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208817-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208817-001AA1cb3db0bc1861…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-961-05ML - Milliliter50383-961d7e62b82-a8a4-4f55-82ae-e316820d7cc712018-01-12
50383-961-06ML - Milliliter50383-9613f41840d-2c37-404e-a01e-859c027d686512018-01-12
50383-961-34ML - Milliliter50383-96107884eed-bc9a-4811-aef4-e13c5c8d7c0e12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-961OXYCODONE HYDROCHLORIDE SOLUTION [AKORN]10Legacy NDC20221112_bb0767d1-b0f8-4975-bf51-631c9fa1b9bb.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-961-06503830961064 TRAY in 1 CASE (50383-961-06) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE (50383-961-05) 4 tray2017-08-100000-00-00NoNoCurrent
50383-961-34503830961341 BOTTLE in 1 CARTON (50383-961-34) > 500 mL in 1 BOTTLE1 bottle2017-08-100000-00-00NoNoCurrent