OXYCODONE HYDROCHLORIDE

Product NDC
60760-223
11-digit product format
607600223
Labeler code
60760
Product ID
60760-223_77e633eb-5173-f9c4-e053-2991aa0acc45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
St Marys Medical Park Pha
Application
ANDA090659
Marketing category
ANDA
Marketing start
2013-01-10
Marketing end
2019-03-31
Substance
OXYCODONE HYDRO
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Ago
DEA schedule
CII
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct60760-223DDiscontinued by firm2026-10-16
excluded packagepackage60760-22360760-223-40DDiscontinued by firm2026-10-16

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 · 24 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 packagepackage60760-223-40d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage60760-223-40f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage60760-223-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage60760-223-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage60760-223-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage60760-223-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage60760-223-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage60760-223-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage60760-223-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage60760-223-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage60760-223-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage60760-223-40557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A090659-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-10
A090659-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-10
A090659-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-10
A090659-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-06
A090659-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-06

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 · 220 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-10c2088c7a36db…
2026-10-15 13:18:302026-09A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-10c2088c7a36db…
2026-10-15 13:18:302026-09A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-10c2088c7a36db…
2026-10-15 13:18:302026-09A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-06c2088c7a36db…
2026-10-15 13:18:302026-09A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-06c2088c7a36db…
2026-09-14 22:38:342026-08A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-1084e616aacf4f…
2026-09-14 22:38:342026-08A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-0684e616aacf4f…
2026-09-14 22:38:342026-08A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-0684e616aacf4f…
2026-08-18 06:07:402026-07A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-10caaa826d4ba7…
2026-08-18 06:07:402026-07A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-06caaa826d4ba7…
2026-08-18 06:07:402026-07A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-06b8a1b40f171c…

Observed Orange Book normalized TE history#

Normalized TE history page 4 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090659-001AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090659-002AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090659-003AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090659-004AB13a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090659-005AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090659-001AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090659-002AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090659-003AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090659-004AB1f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A090659-005AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090659-001AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A090659-002AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A090659-003AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A090659-004AB1e64feba35796…
2022-09-29 23:25 UTC2022-09A090659-005AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090659-001AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090659-002AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090659-003AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090659-004AB1cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090659-005AB1cb3db0bc1861…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-223-40EA - Each60760-2233d1bd558-b913-4cbf-8fc3-7d061d764ba612013-02-13