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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A076758-001OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2004-06-30a50c72e98297…
2026-08-01 22:54:322026-06A076758-002OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2004-06-30a50c72e98297…
2026-08-01 22:54:322026-06A076758-003OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2007-03-19a50c72e98297…
2026-08-01 22:54:322026-06A076758-004OXYCODONE HYDROCHLORIDE10MGTABLET / ORALAB2021-10-12a50c72e98297…
2026-08-01 22:54:322026-06A076758-005OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2021-10-12a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A076758-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A076758-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A076758-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A076758-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A076758-005AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESpecGx LLC928227bf-89c5-4c64-9823-0e84cc6693882024-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 076758
application number: ANDA076758

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67296-0425-12024-06-25C16284748780-1f386c64a-29bc-0266-e053-dadaa90a7c1aOxycodone 5mg
67296-0425-42024-06-25C16284748780-1f386c64a-29bc-0266-e053-dadaa90a7c1aOxycodone 5mg
67296-0425-12023-01-30C16284748780-1f386c64a-29bc-0266-e053-dadaa90a7c1aOxycodone 5mg
67296-0425-42023-01-30C16284748780-1f386c64a-29bc-0266-e053-dadaa90a7c1aOxycodone 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

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