Oxycodone Hydrochloride

Product NDC
0603-4991
11-digit product format
006034991
Labeler code
0603
Product ID
0603-4991_54873134-c3ba-43c2-98b1-df36c08c74d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Oxycodone Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical
Application
ANDA077712
Marketing category
ANDA
Marketing start
2007-01-31
Marketing end
2020-02-29
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
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0603-4991DDiscontinued by firm2026-08-17
excluded packagepackage0603-49910603-4991-21DDiscontinued by firm2026-08-17
excluded packagepackage0603-49910603-4991-28DDiscontinued 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 · 36 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 packagepackage0603-4991-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-4991-28d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4991-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-4991-28f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4991-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-4991-282ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4991-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-4991-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4991-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-4991-28cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4991-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-4991-28cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4991-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-4991-28302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4991-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-4991-28ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4991-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-4991-280efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4991-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-4991-28ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4991-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-4991-28367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4991-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-4991-28557ba5c1ecfa…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 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-4991-21EA - Each0603-4991bc052f2b-7bdd-4d02-ba7a-55604b908eff12012-07-24
0603-4991-28EA - Each0603-49914c8cd9fb-114a-4906-a9d3-efcfd70f1d7412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [QUALITEST PHARMACEUTICALS]9
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]3
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [H.J. HARKINS COMPANY, INC.]2
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOXYCODONE HYDROCHLORIDE TABLET [STAT RX USA LLC]1

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049611oxyCODONE HCl 15 MG Oral TabletPSN994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049618oxyCODONE HCl 30 MG Oral TabletPSN994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049621oxyCODONE HCl 5 MG Oral TabletPSN994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049611oxycodone hydrochloride 15 MG Oral TabletSCD994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049618oxycodone hydrochloride 30 MG Oral TabletSCD994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049621oxycodone hydrochloride 5 MG Oral TabletSCD994dfdaa-6cf7-4177-8cea-b20b56f1512a3
1049611oxyCODONE HCl 15 MG Oral TabletPSN3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049621oxyCODONE HCl 5 MG Oral TabletPSN3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049611oxycodone hydrochloride 15 MG Oral TabletSCD3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049621oxycodone hydrochloride 5 MG Oral TabletSCD3efb2cf8-9b0e-4d76-afb1-c4ecd514d5342
1049611oxyCODONE HCl 15 MG Oral TabletPSN603741db-1545-4c6f-ab7c-be9f5f42e49d1
1049611oxyCODONE HCl 15 MG Oral TabletPSNc3ba0928-0eff-488e-8a29-fffdb1afdb601
1049618oxyCODONE HCl 30 MG Oral TabletPSN603741db-1545-4c6f-ab7c-be9f5f42e49d1
1049611oxycodone hydrochloride 15 MG Oral TabletSCD603741db-1545-4c6f-ab7c-be9f5f42e49d1
1049611oxycodone hydrochloride 15 MG Oral TabletSCDc3ba0928-0eff-488e-8a29-fffdb1afdb601
1049618oxycodone hydrochloride 30 MG Oral TabletSCD603741db-1545-4c6f-ab7c-be9f5f42e49d1