Oxycodone Hydrochloride

Product NDC
0904-6590
11-digit product format
009046590
Labeler code
0904
Product ID
0904-6590_3b973e31-c79c-4615-9bcd-9df008928f6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA077712
Marketing category
ANDA
Marketing start
2015-04-13
Marketing end
2020-02-29
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6590DDiscontinued by firm2026-08-17
excluded packagepackage0904-65900904-6590-61DDiscontinued by firm2026-08-17

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 packagepackage0904-6590-61d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6590-61f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6590-612ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6590-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6590-61cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6590-61cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6590-61302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6590-61ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6590-610efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6590-61ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6590-61367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6590-61557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A077712-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31
A077712-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31
A077712-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02
A077712-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13
A077712-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A077712-001AB
A077712-002AB
A077712-003AB
A077712-004AB
A077712-005AB

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 · 210 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2007-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-03-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2015-04-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2015-04-132680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A077712-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A077712-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077712-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077712-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077712-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077712-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077712-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077712-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077712-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077712-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077712-005AB12680178bc6a6…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6590-61EA - Each0904-6590936d94c2-b6a8-49c9-abc6-c6597b372b9e12017-09-11

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEStrides Pharma Science Limitedf3116ebf-d72c-4e98-aa50-006be4770c862026-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.056bdaac-4a43-42f0-9435-f349d3ccc1282025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDERedpharm Drug439c2de6-3ea5-e829-e063-6294a90aa77d2025-12-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack08977126-9671-4d87-9724-1599ca86e1812025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3ca9f0d9-a40d-4416-e063-6394a90aec8b2025-08-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx3245cd2f-8ad0-b755-e063-6394a90a603c2025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx3a849aeb-b72c-5cde-e063-6394a90a97682025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx32323565-5add-96a9-e063-6294a90a5b4e2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712
Oxycodone HCLOXYCODONE HCLDirect_Rx323148b2-809a-db11-e063-6294a90abe362025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077712
application number: ANDA077712