FDA.reportPublic FDA data

NDC 68071-3603-08 - Dexamethasone

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
68071-3603
Requested NDC
68071-3603-08
Package NDCs from labels
68071-3603-8, 68071-3603-08
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-05-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Tablets, USP Rx onlyNuCare Pharmaceuticals,Inc.2024-05-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3603-8Dexamethasone8 in 1 BOTTLETABLET81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3603DEXAMETHASONE TABLET [NUCARE PHARMACEUTICALS,INC.]1Current NDC, 1 package rows20240509_17f56402-331e-2e3d-e063-6394a90acc0e.zip

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 2 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONESentiss Pharmaceuticals LLC355fa56f-d7a8-444e-9dec-8ba1fa4ab0d82026-04-16Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONESun Pharmaceutical Industries, Inc.641bad60-9b9e-43ea-936e-5c38f27835b22026-04-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.4c619d48-8cf9-4085-8405-c8f066bce19c2026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals, Inc.c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd2026-04-01Warnings, Adverse reactionsExact identifier
application number: ANDA215604
rxcui: 197582
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c33e84ba-4c0c-f738-e053-2995a90aa20a2026-03-27Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals64b46398-9b97-45e8-b1ba-1a202d5744482026-03-26Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLC7ed85675-bc46-4dd6-bb8f-7e98c3eb84e22026-03-20Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONENuCare Pharmaceutical, Inc.4d650d9d-a98a-2dbe-e063-6294a90a00772026-03-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
OZURDEXDEXAMETHASONEAllergan, Inc.4b204f44-6e8a-4d17-803c-268f0b04679f2026-03-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEPreferred Pharmaceuticals Inc.8a143864-e36b-49bf-91b4-c6cc1a9280312026-02-26Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN HYDROCHLORIDE AND DEXAMETHASONEUpsher-Smith Laboratories, LLC9c5994d1-01d1-493c-a6ae-94754cd593892026-02-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONENuCare Pharmaceuticals, Inc.4a808dd5-35b7-e879-e063-6394a90a0bf72026-02-10Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEDirect_Rx0a0db8e7-8474-3d08-e063-6294a90af3f52026-02-06Warnings, Adverse reactionsExact identifier
rxcui: 197581
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke830be9d-0a8c-4712-93c6-284c208d6f0d2026-02-05Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepackb3217057-5945-452c-aa99-ab696fd8b5e72026-02-04Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEA-S Medication Solutionscdd9086d-821f-4ac8-bc49-f1869dffb1502026-01-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONENuCare Pharmaceuticals,Inc.c3b6004a-8cfc-d5f8-e053-2a95a90a3efb2026-01-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc.64577454-d49e-4180-99e6-8461f74b02212026-01-20Warnings, Adverse reactionsExact identifier
rxcui: 343033
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEPreferred Pharmaceuticals Inc.e42d4837-77c2-40c3-8705-20966a51a8222026-01-19Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEBryant Ranch Prepack075717e3-be2a-4bb3-bead-492761bfb2872026-01-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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