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 6 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENDirect_Rx90a11364-fc42-e94e-e053-2a95a90a97822025-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEDIRECT RXa8206207-ad09-83df-e053-2995a90a78b72025-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
rxcui: 1049683
unii: C1ENJ2TE6C
OXYCODONE AND ACETAMINOPHENOXYCODONE AND ACETAMINOPHENAsclemed USA, Inc.71c7a627-6ed9-4f49-8cdc-b3228c021e642025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDERedPharm Drug, Inc.92614a3a-331d-16ad-e053-2a95a90a47cc2025-04-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone HCLOXYCODONE HCLDirect_Rx32323565-5add-96a9-e063-6294a90a5b4e2025-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049611
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENDirect_Rxe4e27022-581e-ba8c-e053-2a95a90a1ae42025-04-07Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HCLOXYCODONE HCLDirect_Rx323148b2-809a-db11-e063-6294a90abe362025-04-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049686
unii: C1ENJ2TE6C
Oxycodone HCLOXYCODONE HCLDirect_Rx31189587-a2dc-e0a1-e063-6394a90ae17d2025-03-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAmerican Health Packaging0a6b0659-6816-4f44-81bd-9bac4da5380d2025-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepacke2e52a0e-a80b-4225-b034-37a62f839d922025-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
PercocetOXYCODONE/APAPDirect_Rxee151649-b52a-0a51-e053-2a95a90a6c352025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEAsclemed USA, Inc.c10cc127-8756-4ddc-9f46-1e003ef271dc2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049621
rxcui: 1049611
rxcui: 1049618
rxcui: 1049683
rxcui: 1049686
unii: C1ENJ2TE6C
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLCb9847cc7-67a2-408d-93cf-f9cf420346dd2024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 1049621
unii: C1ENJ2TE6C
OXYCODONE HYDROCHLORIDEOXYCODONE HYDROCHLORIDEQuality Care Products LLC4cadb809-157d-49cc-97b4-3276594f19d22024-12-19Warnings, Adverse reactionsExact identifier
rxcui: 1049611
rxcui: 1049618
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEPrecision Dose, Inc.f849c7cc-fa85-47eb-be30-1be137913bf92024-12-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA203638
ndc (package): 68094-005-61
ndc (package): 68094-005-59
ndc (product): 68094-005
ndc11 (package): 68094000559
rxcui: 1049611
spl id: 31203769-a951-4d0c-8d60-4cb7715e26e8
spl set id: f849c7cc-fa85-47eb-be30-1be137913bf9
unii: C1ENJ2TE6C
Oxycodone HydchlorideOXYCODONE HYDCHLORIDEQuality Care Products LLC28156b13-0ba9-4dc4-be24-9c3070a7e1cc2024-12-16Warnings, Adverse reactionsExact identifier
rxcui: 1049683
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENQuality Care products LLC3f2b939c-2206-469b-85a4-b0ee9ba25be82024-12-16Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEBryant Ranch Prepackd9841f2d-d182-4888-9a3c-68e1afb3e19c2024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1049618
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENNuCare Pharmaceuticals,Inc.223fe2b4-aa12-81fd-e063-6394a90a6c082024-09-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C

Reported adverse events (FAERS/openFDA)#

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