oxycodone hydrochloride

Product NDC
57664-187
11-digit product format
576640187
Labeler code
57664
Product ID
57664-187_11c23682-e42c-4e33-b67f-acdcc8be3b38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA090659
Marketing category
ANDA
Marketing start
2009-05-12
Marketing end
0000-00-00
Substance
OXYCODONE HYDROCHLORIDE
Active strength
15 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct57664-187DDiscontinued by firm2026-10-05
excluded packagepackage57664-18757664-187-88DDiscontinued 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 · 4 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 packagepackage57664-187-88d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57664-187-88f5e01cc5f278…a2eaf40c39c3…

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 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
57664-187-88EA - Each57664-1879fb9aeba-1b1c-47b3-a83a-22285138285612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]10
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJOXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN2c6296ee-779a-419b-e054-00144ff8d46c2
1049611oxycodone hydrochloride 15 MG Oral TabletSCD2c6296ee-779a-419b-e054-00144ff8d46c2
1049611oxyCODONE HCl 15 MG Oral TabletPSN2b48c2dd-e62e-4f53-e054-00144ff88e881
1049611oxycodone hydrochloride 15 MG Oral TabletSCD2b48c2dd-e62e-4f53-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57664-187-8857664018788100 TABLET in 1 BOTTLE (57664-187-88) 100 tablet2009-05-120000-00-00NoNoCurrent