Oxycodone Hydrochloride

Product NDC
67296-1324
11-digit product format
672961324
Labeler code
67296
Product ID
67296-1324_d611362d-3d75-2e57-e053-2995a90a40de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA206456
Marketing category
ANDA
Marketing start
2015-06-17
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 productproduct67296-1324IInactivated by FDA2026-08-03
excluded packagepackage67296-132467296-1324-2IInactivated by FDA2026-08-03
excluded packagepackage67296-132467296-1324-6IInactivated by FDA2026-08-03

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 · 48 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 productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1324-6IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage67296-1324-2IInactivated by FDAd630ba8d3edf…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 packagepackage67296-1324-6IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage67296-1324-2IInactivated by FDAf5e01cc5f278…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 packagepackage67296-1324-6IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage67296-1324-2IInactivated by FDA2ef7874e63bc…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 packagepackage67296-1324-6IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage67296-1324-2IInactivated by FDAa1b67e2a42f9…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 packagepackage67296-1324-6IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage67296-1324-2IInactivated by FDAcfe11265f3b6…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 packagepackage67296-1324-6IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage67296-1324-2IInactivated by FDAcdf11ea48f46…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 packagepackage67296-1324-6IInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage67296-1324-2IInactivated by FDA302b2466d912…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 packagepackage67296-1324-6IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage67296-1324-2IInactivated by FDAed331223b511…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 packagepackage67296-1324-6IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage67296-1324-2IInactivated by FDA0efc9e666f02…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 packagepackage67296-1324-6IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage67296-1324-2IInactivated by FDAad56d346431e…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 packagepackage67296-1324-6IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage67296-1324-2IInactivated by FDA367a005e9d99…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 packagepackage67296-1324-6IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage67296-1324-2IInactivated by FDA557ba5c1ecfa…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 packagepackage67296-1324-6IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-1324-2IInactivated 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 packagepackage67296-1324-6IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-1324-2IInactivated 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 packagepackage67296-1324-6IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-1324-2IInactivated by FDA1332a3947898…d4bfe170f9cd…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1324-6EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage67296-1324-2EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A206456-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16

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 UTC2026-02A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-166a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-1603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-162680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-165bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-1679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-161e350fbaab3a…
2024-05-31 18:47 UTC2024-05A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-168072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-165c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-165d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-164b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-1674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-16bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-16782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-1687673890dc5c…
2021-03-12 10:30 UTC2021-03A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-165aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-168869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-16c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-163f01610625f2…
2019-09-15 20:21 UTC2019-09A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-16b00525d2431f…
2019-07-19 19:46 UTC2019-07A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAA2015-06-16ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-166a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-161c564ffb4f44…
2023-12-20 04:57 UTC2023-12A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-169b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-163f0d92c62455…
2023-05-13 08:27 UTC2023-05A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16053a50430f4f…
2023-01-26 05:58 UTC2023-01A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-163bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-163a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A206456-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORAL2015-06-16cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-04-08 23:34 UTC2022-04A206456-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A206456-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A206456-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A206456-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A206456-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A206456-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A206456-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A206456-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A206456-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A206456-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A206456-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A206456-001AA1ea99ee380514…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-1324-22024-01-30C16284748780-11030e365-5b9e-111a-e063-dadaa90a10e25021a19a-5089-0161-e054-00144ff88e88
67296-1324-62024-01-30C16284748780-11030e365-5b9e-111a-e063-dadaa90a10e25021a19a-5089-0161-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1324-2Oxycodone Hydrochloride200 mL in 1 BOTTLE, PLASTICSOLUTION2005
67296-1324-6Oxycodone Hydrochloride60 mL in 1 BOTTLE, PLASTICSOLUTION605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1324OXYCODONE HYDROCHLORIDE SOLUTION [REDPHARM DRUG, INC.]5Legacy NDC, 2 package rows20220121_5021a19a-5089-0161-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049604oxyCODONE HCl 5 MG in 5 mL Oral SolutionPSN5021a19a-5089-0161-e054-00144ff88e885
1049604oxycodone hydrochloride 1 MG/ML Oral SolutionSCD5021a19a-5089-0161-e054-00144ff88e885
1049604oxycodone hydrochloride 5 MG per 5 ML Oral SolutionSY5021a19a-5089-0161-e054-00144ff88e885

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1324-267296132402200 mL in 1 BOTTLE, PLASTIC (67296-1324-2) 200 ml2015-06-170000-00-00NoNoCurrent
67296-1324-66729613240660 mL in 1 BOTTLE, PLASTIC (67296-1324-6) 60 ml2015-06-170000-00-00NoNoCurrent