FDA.reportPublic FDA data

OXYCODONE HYDROCHLORIDE

Product NDC
71335-1245
11-digit product format
713351245
Labeler code
71335
Product ID
71335-1245_a22286fc-994f-48fb-b106-0de005e83d94
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA091393
Marketing category
ANDA
Marketing start
2013-10-18
Substance
OXYCODONE HYDROCHLORIDE
Active strength
30 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
ndc (product): 71335-1245
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
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYCODONE HYDROCHLORIDE30 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
1049618Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
685d9709-028e-4422-bf0c-fde577b718a2Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1245-1OXYCODONE HYDROCHLORIDE60 in 1 BOTTLETABLET603
71335-1245-2OXYCODONE HYDROCHLORIDE90 in 1 BOTTLETABLET903
71335-1245-3OXYCODONE HYDROCHLORIDE120 in 1 BOTTLETABLET1203
71335-1245-4OXYCODONE HYDROCHLORIDE30 in 1 BOTTLETABLET303
71335-1245-5OXYCODONE HYDROCHLORIDE100 in 1 BOTTLETABLET1003
71335-1245-6OXYCODONE HYDROCHLORIDE40 in 1 BOTTLETABLET403
71335-1245-7OXYCODONE HYDROCHLORIDE18 in 1 BOTTLETABLET183
71335-1245-8OXYCODONE HYDROCHLORIDE28 in 1 BOTTLETABLET283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1245OXYCODONE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 8 package rows20240724_685d9709-028e-4422-bf0c-fde577b718a2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1049618oxyCODONE HCl 30 MG Oral TabletPSN685d9709-028e-4422-bf0c-fde577b718a23
1049618oxycodone hydrochloride 30 MG Oral TabletSCD685d9709-028e-4422-bf0c-fde577b718a23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1245-17133512450160 TABLET in 1 BOTTLE (71335-1245-1) 60 tablet2019-09-200000-00-00NoNoCurrent
71335-1245-27133512450290 TABLET in 1 BOTTLE (71335-1245-2) 90 tablet2019-05-280000-00-00NoNoCurrent
71335-1245-371335124503120 TABLET in 1 BOTTLE (71335-1245-3) 120 tablet2024-07-090000-00-00NoNoCurrent
71335-1245-47133512450430 TABLET in 1 BOTTLE (71335-1245-4) 30 tablet2019-07-080000-00-00NoNoCurrent
71335-1245-571335124505100 TABLET in 1 BOTTLE (71335-1245-5) 100 tablet2024-07-090000-00-00NoNoCurrent
71335-1245-67133512450640 TABLET in 1 BOTTLE (71335-1245-6) 40 tablet2024-07-090000-00-00NoNoCurrent
71335-1245-77133512450718 TABLET in 1 BOTTLE (71335-1245-7) 18 tablet2024-07-090000-00-00NoNoCurrent
71335-1245-87133512450828 TABLET in 1 BOTTLE (71335-1245-8) 28 tablet2024-07-090000-00-00NoNoCurrent