FDA.reportPublic FDA data

NDC 71335-0981-00 - Oxycodone Hydrochloride

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-0981
Requested NDC
71335-0981-00
Package NDCs from labels
71335-0981-1, 71335-0981-2, 71335-0981-3, 71335-0981-4, 71335-0981-5, 71335-0981-6, 71335-0981-7, 71335-0981-8, 71335-0981-9, 71335-0981-0, 71335-0981-00
Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxycodone Hydrochloride - Bryant Ranch PrepackBryant Ranch Prepack2024-05-30HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-0981-12024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-22024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-32024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-42024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-52024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-62024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-72024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-82024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-92024-05-31These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-12024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-22024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-32024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-42024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-52024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-62024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-72024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-82024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950
71335-0981-92024-01-30These highlights do not include all the information needed to use OXYCODONE HCl TABLETS safely and effectively. See full prescribing information for OXYCODONE HCl TABLETS. OXYCODONE HCl tablets, for oral use, CII Initial U.S. Approval: 1950

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0981-0Oxycodone Hydrochloride15 in 1 BOTTLETABLET15101
71335-0981-1Oxycodone Hydrochloride30 in 1 BOTTLETABLET30101
71335-0981-2Oxycodone Hydrochloride60 in 1 BOTTLETABLET60101
71335-0981-3Oxycodone Hydrochloride90 in 1 BOTTLETABLET90101
71335-0981-4Oxycodone Hydrochloride56 in 1 BOTTLETABLET56101
71335-0981-5Oxycodone Hydrochloride100 in 1 BOTTLETABLET100101
71335-0981-6Oxycodone Hydrochloride120 in 1 BOTTLETABLET120101
71335-0981-7Oxycodone Hydrochloride50 in 1 BOTTLETABLET50101
71335-0981-8Oxycodone Hydrochloride40 in 1 BOTTLETABLET40101
71335-0981-9Oxycodone Hydrochloride20 in 1 BOTTLETABLET20101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0981OXYCODONE HYDROCHLORIDE (OXYCODONE) TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20240601_4e9e945d-5ffc-48de-99fa-3fb36c5bc2b9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0981-1EA - Each71335-098142de481b-a53a-4e06-9173-ce440317be6812020-09-14
71335-0981-2EA - Each71335-09815636f1cb-9e4b-45e7-bb4a-30d281825b5612020-09-14
71335-0981-3EA - Each71335-09819498c3ba-949d-4465-ad48-835e91272e6812020-09-14
71335-0981-9EA - Each71335-0981a350b85c-fcaa-498b-b8f0-ce7454f166c812025-10-14

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 9 · 170 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEKVK-TECH, INC.338b5391-e5f7-40a2-8b15-57f47cbc48132026-09-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a68a27-4422-5ba0-e063-6294a90ac5502026-08-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESpecGx LLC928227bf-89c5-4c64-9823-0e84cc6693882026-08-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
rxcui: 1049611
rxcui: 1049618
rxcui: 1049683
rxcui: 1049686
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy585405bc-8b85-286f-e063-6394a90aa5cd2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049611
unii: C1ENJ2TE6C
NalocetOXYCODONE AND ACETAMINOPHENForte Bio-Pharma LLCf5f7dfca-a5c7-4445-8a5e-9ec62f33f5be2026-08-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEKVK-Tech, Inc.744f5d1c-7427-492c-8994-c8e817793e532026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
oxycodone and acetaminophenOXYCODONE AND ACETAMINOPHENFH2 Pharma LLC88d97caf-bcf5-3cde-e053-2995a90acf4a2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
ProlateOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENForte Bio-Pharma LLC9d75ad3b-bc9b-0c22-e053-2a95a90ac71e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
PERCOCETOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLC4dd36cf5-8f73-404a-8b1d-3bd53bd90c252026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSpecGx LLCf2137f1a-b49a-40bd-97ac-cd6b36e295f42026-07-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy57afed61-79db-ca43-e063-6394a90a68eb2026-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049683
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONEMajor Pharmaceuticals6b6db42b-9821-4aa6-8566-297037d840792026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049621
rxcui: 1049611
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDESt. Mary's Medical Park Pharmacy3ccf459a-fb11-e137-e063-6394a90a5a802026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone Hydrochloride and AcetaminophenOXYCODONE HYDROCHLORIDE AND ACETAMINOPHENSt. Mary's Medical Park Pharmacy40a882d6-a4db-1ad9-e063-6394a90a72682026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEBryant Ranch Prepack685d9709-028e-4422-bf0c-fde577b718a22026-07-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049618
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENMajor Pharmaceuticals1d52272f-a607-4002-a61c-341964522b822026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackac6b4a26-7ead-458e-8a3d-591aa07093432026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEywa Pharma Incc801963d-f54d-4ed5-82c4-8b278528d3dc2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack25c03c47-0057-41b6-a530-c6ea85eb750f2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackbb33bf7f-aa70-4e8a-91b2-4e0400dc328e2026-06-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049683
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.