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 8 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepackbc7fdf7e-ad4e-4a04-b35c-2233cc7e5f152024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack4e9e945d-5ffc-48de-99fa-3fb36c5bc2b92024-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONEBryant Ranch Prepack9da42120-0214-45cb-bb98-9a7739e72d432024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
rxcui: 1049618
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack71b1a9be-3231-4b09-a195-d5893104bd4a2024-05-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDENuCare Pharmaceuticals,Inc.17f7946d-e889-b736-e063-6394a90a42e02024-05-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENBryant Ranch Prepack4da8a7bd-0d2e-452c-afb5-fed4e230a9bd2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENLupin Pharmaceuticals,Inc.916ff456-a27e-49dc-a312-274126a8c30c2024-02-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENXLCare Pharmaceuticals, Inc.7f3c6dd7-6bc8-450e-aded-997f9cf63a8f2024-02-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDELupin Pharmaceuticals,Inc.801cb437-c189-44f5-83eb-a51c365d8a6b2024-01-30Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
rxcui: 1049611
rxcui: 1049618
rxcui: 1049683
rxcui: 1049686
unii: C1ENJ2TE6C
Oxycodone Hydrochloride Oral SolutionOXYCODONE HYDROCHLORIDE ORAL SOLUTIONAurolife Pharma, LLC0b3fa92e-8351-4401-860d-4bba8a7155e62024-01-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDENovel Laboratories, Inc.69410bf3-0d3a-41f9-b10a-c4ee3770f7282023-12-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC391701e5-2035-43fa-91ce-d27a1af194922023-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEpic Pharma, LLCcff1eee3-7c02-4f6c-acc5-1f6dcbab92c02022-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
rxcui: 1049611
rxcui: 1049618
rxcui: 1049683
rxcui: 1049686
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP78933d4a-d78a-43bc-9052-a032901ee0502022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP5df7c033-0f31-45bc-8c34-3da45635e66d2022-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LPad03068c-1af4-46ce-bdea-c2745b1c1e522022-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENProficient Rx LP484a4323-0758-439d-844f-f04d7e5ef6f32022-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.3e89f02d-b6e7-4641-82d4-f756518a89142022-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

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