FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
72189-094
11-digit product format
721890094
Labeler code
72189
Product ID
72189-094_36d68732-0635-1380-e063-6394a90a69c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA091393
Marketing category
ANDA
Marketing start
2020-06-15
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
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
A091393-001OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31
A091393-002OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31
A091393-003OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31
A091393-004OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31
A091393-005OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A091393-001AB
A091393-002AB
A091393-003AB
A091393-004AB
A091393-005AB

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 22:54:322026-06A091393-001OXYCODONE HYDROCHLORIDE5MGTABLET / ORALAB2009-08-31a50c72e98297…
2026-08-01 22:54:322026-06A091393-002OXYCODONE HYDROCHLORIDE10MGTABLET / ORALABRS2009-08-31a50c72e98297…
2026-08-01 22:54:322026-06A091393-003OXYCODONE HYDROCHLORIDE15MGTABLET / ORALAB2009-08-31a50c72e98297…
2026-08-01 22:54:322026-06A091393-004OXYCODONE HYDROCHLORIDE20MGTABLET / ORALAB2009-08-31a50c72e98297…
2026-08-01 22:54:322026-06A091393-005OXYCODONE HYDROCHLORIDE30MGTABLET / ORALAB2009-08-31a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A091393-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A091393-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A091393-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A091393-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A091393-005AB1a50c72e98297…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-TECH,INCe73897d6-b920-4300-a564-5dbc9c8e9fe92026-06-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY424fdfc7-1c92-2e62-e063-6394a90a136b2026-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEAmerican Health Packagingaa7ac2bf-d9ed-445d-b394-4d3fe39780ca2025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEST. MARY'S MEDICAL PARK PHARMACY3cd01fb7-b59c-fc5d-e063-6394a90a21d22025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
ndc (product): 72189-094
Oxycodone HCLOXYCODONE HCLDirect_Rx31189587-a2dc-e0a1-e063-6394a90ae17d2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLCb9847cc7-67a2-408d-93cf-f9cf420346dd2024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products LLC4cadb809-157d-49cc-97b4-3276594f19d22024-12-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLC28156b13-0ba9-4dc4-be24-9c3070a7e1cc2024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.17f7946d-e889-b736-e063-6394a90a42e02024-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091393
application number: ANDA091393

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
C1ENJ2TE6CInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049214Internal RxNorm lookup
1049225Internal RxNorm lookup
1049621Internal RxNorm lookup
1049683Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a8206207-ad09-83df-e053-2995a90a78b7Available 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
72189-094-302025-06-13C16284748780-12cef2736-73ea-d83d-e063-dadaa90ab31fOXYCODONE
72189-094-602025-06-13C16284748780-12cef2736-73ea-d83d-e063-dadaa90ab31fOXYCODONE
72189-094-902025-06-13C16284748780-12cef2736-73ea-d83d-e063-dadaa90ab31fOXYCODONE
72189-094-302025-01-30C16284748780-12cef2736-73ea-d83d-e063-dadaa90ab31fOXYCODONE
72189-094-602025-01-30C16284748780-12cef2736-73ea-d83d-e063-dadaa90ab31fOXYCODONE
72189-094-902025-01-30C16284748780-12cef2736-73ea-d83d-e063-dadaa90ab31fOXYCODONE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72189-094-30OXYCODONE HYDROCHLORIDE30 in 1 BOTTLETABLET3010
72189-094-60OXYCODONE HYDROCHLORIDE60 in 1 BOTTLETABLET6010
72189-094-90OXYCODONE HYDROCHLORIDE90 in 1 BOTTLETABLET9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-094-30EA - Each72189-094149da0b8-52ee-4ecf-8d26-f9259c26d57b12020-07-13
72189-094-90EA - Each72189-0948efb2df1-3d62-4e73-b45d-e0b78a5d94ca12025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72189-094OXYCODONE HYDROCHLORIDE TABLET OXYCODONE AND ACETAMINOPHEN TABLET [DIRECT RX]9Current NDC, Legacy NDC, 3 package rows20231025_a8206207-ad09-83df-e053-2995a90a78b7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049214oxyCODONE 10 MG / acetaminophen 325 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049225oxyCODONE 7.5 MG / acetaminophen 325 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049683oxyCODONE HCl 10 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049621oxyCODONE HCl 5 MG Oral TabletPSNa8206207-ad09-83df-e053-2995a90a78b710
1049214acetaminophen 325 MG / oxycodone hydrochloride 10 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049225acetaminophen 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049683oxycodone hydrochloride 10 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049621oxycodone hydrochloride 5 MG Oral TabletSCDa8206207-ad09-83df-e053-2995a90a78b710
1049214APAP 325 MG / oxycodone hydrochloride 10 MG Oral TabletSYa8206207-ad09-83df-e053-2995a90a78b710
1049225APAP 325 MG / oxycodone hydrochloride 7.5 MG Oral TabletSYa8206207-ad09-83df-e053-2995a90a78b710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72189-094-307218900943030 TABLET in 1 BOTTLE (72189-094-30) 30 tablet2020-06-150000-00-00NoNoCurrent
72189-094-607218900946060 TABLET in 1 BOTTLE (72189-094-60) 60 tablet2020-06-150000-00-00NoNoCurrent
72189-094-907218900949090 TABLET in 1 BOTTLE (72189-094-90) 90 tablet2020-06-150000-00-00NoNoCurrent