Oxycodone Hydrochloride

Product NDC
66689-403
11-digit product format
666890403
Labeler code
66689
Product ID
66689-403_6f0d315a-4d02-4548-b993-ba648c596bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
VistaPharm, Inc.
Application
NDA201194
Marketing category
NDA
Marketing start
2012-03-15
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66689-403DDiscontinued by firm2026-08-11
excluded packagepackage66689-40366689-403-16DDiscontinued by firm2026-08-11

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 · 18 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 packagepackage66689-403-16d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66689-403-16f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66689-403-162ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66689-403-16a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66689-403-16cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66689-403-16cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66689-403-16302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66689-403-16ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66689-403-160efc9e666f02…f202fb6c5f17…

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
N201194-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-12

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 UTC2026-02N201194-001OXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N201194-001OXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N201194-001OXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N201194-001OXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201194-001OXYCODONE HYDROCHLORIDE5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION / ORALRLD2012-01-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-123f01610625f2…
2019-09-15 20:21 UTC2019-09N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALRLD2012-01-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N201194-001OXYCODONE HYDROCHLORIDE5MG/5MLSOLUTION / ORALAARLD, RS2012-01-12cb3db0bc1861…

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 ZIP2022-06N201194-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N201194-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N201194-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N201194-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N201194-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N201194-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N201194-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03N201194-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N201194-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N201194-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N201194-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09N201194-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07N201194-001AA1ea99ee380514…
2023-12-20 04:57 UTC2023-12N201194-001AA1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N201194-001AA1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N201194-001AA19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N201194-001AA1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N201194-001AA13f0d92c62455…
2023-05-13 08:27 UTC2023-05N201194-001AA1053a50430f4f…
2023-01-26 05:58 UTC2023-01N201194-001AA13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N201194-001AA13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N201194-001AA1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N201194-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N201194-001AA1cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N201194-001M-142024-07-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N201194-001M-142024-07-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N201194-001M-142024-07-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N201194-001M-142024-07-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N201194-001M-142024-07-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N201194-001M-142024-07-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N201194-001M-142024-07-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N201194-001M-142024-07-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N201194-001M-142024-07-218072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N201194-001M-142024-07-216a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N201194-001M-142024-07-211c564ffb4f44…

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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-403-16ML - Milliliter66689-4035ebc6888-7b67-44e6-8bfa-98bd26f1dfce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-403OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC]24Legacy NDC20240427_d7dceba3-96dc-4593-bc8f-318052bdb520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049604oxyCODONE HCl 5 MG in 5 mL Oral SolutionPSN6a4d8151-f28e-366b-e053-2991aa0a13596
1049604oxycodone hydrochloride 1 MG/ML Oral SolutionSCD6a4d8151-f28e-366b-e053-2991aa0a13596
1049604oxycodone hydrochloride 5 MG per 5 ML Oral SolutionSY6a4d8151-f28e-366b-e053-2991aa0a13596

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66689-403-1666689040316500 mL in 1 BOTTLE (66689-403-16) 500 ml2012-03-150000-00-00NoNoCurrent