FDA.reportPublic FDA data

NDC 66689-401-01 - 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
66689-401
Requested NDC
66689-401-01
Package NDCs from labels
66689-401-01, 66689-401-50
Manufacturer
VistaPharm, LLC
Effective date
2024-04-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Oxycodone Hydrochloride - VistaPharm, LLCVistaPharm, LLC2024-04-26HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66689-401-502024-01-30C16284748780-11030e364-fb51-111a-e063-dadaa90a10e2These highlights do not include all the information needed to use OXYCODONE HYDROCHLORIDE ORAL SOLUTION safely and effectively. See full prescribing information for OXYCODONE HYDROCHLORIDE ORAL SOLUTION. Oxycodone Hydrochloride oral solution CII Initial U.S. Approval: 1950

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66689-401OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM, LLC]24Legacy NDC20240427_d7dceba3-96dc-4593-bc8f-318052bdb520.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66689-401-01ML - Milliliter66689-401dc97b601-7870-4390-bd53-4ac15acfdb2b12012-07-24
66689-401-50ML - Milliliter66689-401b59ec39e-d4a4-48ac-8af9-69f5ed9c1b8d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYCODONE HYDROCHLORIDEACTIVE INGREDIENTC1ENJ2TE6COXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
OXYCODONEACTIVE MOIETYCD35PMG570OXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1
WATERINACTIVE INGREDIENT059QF0KO0ROXYCODONE HYDROCHLORIDE SOLUTION [VISTAPHARM INC.]1

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 9 of 37 · 736 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
unii: PDC6A3C0OX
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEANI Pharmaceuticals, Inc.5df92fed-6194-4905-9ef2-9eed0d2e80862026-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone and AcetaminophenOXYCODONE AND ACETAMINOPHENAvPAK7055acd5-1cbb-397e-e053-2a91aa0a38522026-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
oxycodone hydrochlorideOXYCODONE HYDROCHLORIDEHikma Pharmceuticals USA Inc.d8e87c66-f872-4e1d-9ade-ef11490af63b2026-01-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Oxycodone HydrochlorideOXYCODONE HYDROCHLORIDEEywa Pharma Inc685f409f-946f-4b7e-8130-5ad7b92a5e7a2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: C1ENJ2TE6C
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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