oxycodone hydrochloride

Product NDC
55700-020
11-digit product format
557000020
Labeler code
55700
Product ID
55700-020_a190b54d-0f06-4d2d-b08b-65ae19526c38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA090659
Marketing category
ANDA
Marketing start
2012-11-19
Marketing end
2021-05-31
Substance
OXYCODONE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55700-020DDiscontinued by firm2026-10-05
excluded packagepackage55700-02055700-020-30DDiscontinued by firm2026-10-05
excluded packagepackage55700-02055700-020-60DDiscontinued by firm2026-10-05
excluded packagepackage55700-02055700-020-90DDiscontinued by firm2026-10-05

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 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 packagepackage55700-020-60d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-020-30d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55700-020-90d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-020-60f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-020-30f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55700-020-90f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-020-602ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-020-302ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55700-020-902ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-020-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-020-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55700-020-90a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-020-60cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-020-30cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55700-020-90cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-020-60cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-020-30cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55700-020-90cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-020-60302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-020-30302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55700-020-90302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-020-60ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-020-30ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55700-020-90ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-020-600efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-020-300efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55700-020-900efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-020-60ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-020-30ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55700-020-90ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-020-60367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-020-30367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55700-020-90367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-020-60557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-020-30557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55700-020-90557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 215 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090659-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORAL2009-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090659-002OXYCODONE HYDROCHLORIDE15MGTABLET / ORAL2009-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090659-003OXYCODONE HYDROCHLORIDE30MGTABLET / ORAL2009-04-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090659-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORAL2012-11-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090659-005OXYCODONE HYDROCHLORIDE10MGTABLET / ORAL2012-11-0603ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 140 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090659-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090659-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090659-003AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090659-004AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090659-005AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090659-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090659-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090659-003AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090659-004AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A090659-005AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090659-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090659-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090659-003AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090659-004AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090659-005AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090659-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090659-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090659-003AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090659-004AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A090659-005AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090659-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090659-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090659-003AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090659-004AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A090659-005AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090659-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090659-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090659-003AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090659-004AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A090659-005AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090659-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090659-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090659-003AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090659-004AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A090659-005AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090659-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090659-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090659-003AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090659-004AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A090659-005AB1782e0a99824c…

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
55700-020-30EA - Each55700-020d7251778-f89d-4574-be9a-7b594a764e3612019-10-07
55700-020-60EA - Each55700-0200669f87b-6c4f-4533-b6e5-87d4c70401df12014-01-04
55700-020-90EA - Each55700-020c75c9227-c144-4fa5-bc22-054f52436c7a12014-01-04

DailyMed Socrata Ingredients#

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-020-305570000203030 TABLET in 1 BOTTLE (55700-020-30) 30 tablet2012-11-190000-00-00NoNoCurrent
55700-020-605570000206060 TABLET in 1 BOTTLE (55700-020-60) 60 tablet2012-11-190000-00-00NoNoCurrent
55700-020-905570000209090 TABLET in 1 BOTTLE (55700-020-90) 90 tablet2012-11-190000-00-00NoNoCurrent