FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
67296-0425
11-digit product format
672960425
Labeler code
67296
Product ID
67296-0425_3252751e-38fb-6056-e063-6394a90a1340
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
oxycodone hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA076758
Marketing category
ANDA
Marketing start
2009-07-30
Substance
OXYCODONE HYDROCHLORIDE
Active strength
5 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA], Opioid Agonist [EPC]
DEA schedule
CII
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0425-48af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage67296-0425-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0425-4834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage67296-0425-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0425-41332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage67296-0425-11332a3947898…d4bfe170f9cd…

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
A076758-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-30
A076758-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-30
A076758-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-19
A076758-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-12
A076758-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A076758-001AB
A076758-002AB
A076758-003AB
A076758-004AB
A076758-005AB

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 5 · 194 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-30caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-19caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-12caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-122680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 194 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A076758-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-004AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A076758-005AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A076758-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A076758-005AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A076758-005AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A076758-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A076758-005AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A076758-005AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A076758-005AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A076758-005AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-004AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A076758-005AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
OXYCODONE HYDROCHLORIDE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
C1ENJ2TE6CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049621Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92614a3a-331d-16ad-e053-2a95a90a47ccAvailable on FDA.report

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
67296-0425-12024-06-25Oxycodone 5mg
67296-0425-42024-06-25Oxycodone 5mg
67296-0425-12023-01-30Oxycodone 5mg
67296-0425-42023-01-30Oxycodone 5mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-0425-1OXYCODONE HYDROCHLORIDE20 in 1 BOTTLETABLET2015
67296-0425-4OXYCODONE HYDROCHLORIDE4 in 1 BOTTLETABLET415

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-0425OXYCODONE HYDROCHLORIDE TABLET [REDPHARM DRUG, INC.]15Current NDC, Legacy NDC, 2 package rows20250410_92614a3a-331d-16ad-e053-2a95a90a47cc.zip

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESpecGx LLC928227bf-89c5-4c64-9823-0e84cc6693882026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076758
application number: ANDA076758
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedpharm Drug5301d432-7fca-2d72-e063-6394a90a18a42026-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076758
application number: ANDA076758
ndc (product): 67296-0425
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.92614a3a-331d-16ad-e053-2a95a90a47cc2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076758
application number: ANDA076758
ndc (product): 67296-0425

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049621oxyCODONE HCl 5 MG Oral TabletPSN92614a3a-331d-16ad-e053-2a95a90a47cc15
1049621oxycodone hydrochloride 5 MG Oral TabletSCD92614a3a-331d-16ad-e053-2a95a90a47cc15
1049621oxyCODONE HCl 5 MG Oral TabletPSN5301d432-7fca-2d72-e063-6394a90a18a41
1049621oxycodone hydrochloride 5 MG Oral TabletSCD5301d432-7fca-2d72-e063-6394a90a18a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-0425-16729604250120 TABLET in 1 BOTTLE (67296-0425-1) 20 tablet2019-01-010000-00-00NoNoCurrent
67296-0425-2672960425026 TABLET in 1 BOTTLE (67296-0425-2)6 tablet2004-06-300Current
67296-0425-36729604250310 TABLET in 1 BOTTLE (67296-0425-3)10 tablet2004-06-300Current
67296-0425-4672960425044 TABLET in 1 BOTTLE (67296-0425-4) 4 tablet2019-01-010000-00-00NoNoCurrent
67296-0425-56729604250512 TABLET in 1 BOTTLE (67296-0425-5)12 tablet2004-06-300Current
67296-0425-86729604250840 TABLET in 1 BOTTLE (67296-0425-8)40 tablet2004-06-300Current