FDA.reportPublic FDA data

NDC 68094-005-59 - 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
68094-005
Requested NDC
68094-005-59
Package NDCs from labels
68094-005-59, 68094-005-61
Manufacturer
Precision Dose, Inc.
Effective date
2024-12-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxycodone Hydrochloride - Precision Dose, Inc.Precision Dose, Inc.2024-12-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-005-59Oxycodone Hydrochloride10 in 1 BLISTER PACKTABLET107
68094-005-61Oxycodone Hydrochloride10 in 1 CARTONTABLET107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-005OXYCODONE HYDROCHLORIDE TABLET [PRECISION DOSE, INC.]7Current NDC, Legacy NDC, 2 package rows20250207_f849c7cc-fa85-47eb-be30-1be137913bf9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-005-59EA - Each68094-005afba1f95-14ac-469f-9521-13892cd1a5cb12018-02-20
68094-005-61EA - Each68094-005b13b545b-fa08-4135-a865-c32a4abb886412017-03-06

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 7 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDELupin Pharmaceuticals, Inc.3eddd18b-695a-4e53-a76c-f6779515b9182024-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.ef58f422-682e-6896-e053-2a95a90a1f2d2024-09-06Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack7dc10b86-c6cd-4012-b7b9-b694ccf4f7682024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack1bcddbe1-c453-43ec-a822-9e993b885a5f2024-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackf11f356e-967d-4099-9d87-5497790b397c2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepack261132f9-ab96-4901-a660-a80c3e0f9d862024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepackc12c26be-ba05-4d25-a2bf-f87623c6ae572024-08-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
ENDOCETOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3b8ef94a-da42-46b5-9fa9-2fac9ed6e7c32024-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAmerican Health Packaging03c9ff0d-46e8-448c-944a-7ad59d1afd6d2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone hydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.1bb147d4-1ab6-dd70-e063-6394a90a67a82024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
rxcui: 1049611
rxcui: 1049618
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.9e4024f4-0f60-dfef-e053-2995a90ac3662024-06-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.925f9787-3d1c-0189-e053-2a95a90a29722024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4a873428-bb5a-4e48-9185-2a27f289110d2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack88d05136-7b04-4b25-af1c-6bc72fdbcbd72024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack96173ce4-4836-43ae-9797-5246f830643a2024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackb2510d72-bf63-4c9d-ac5e-7bacd993fa102024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049686
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack3791abd3-fcdf-4c8d-b46d-db6e5c8057702024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack0c85d1b8-ea42-421d-a305-4d338b47150f2024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack232d44d2-3924-4d35-873c-d2aef75e9a412024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049618
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackd248ceba-9492-4348-aa07-31c9c73a36202024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049611
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

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