FDA.reportPublic FDA data

NDC 68788-8763-01 - 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
68788-8763
Requested NDC
68788-8763-01
Package NDCs from labels
68788-8763-1, 68788-8763-2, 68788-8763-3, 68788-8763-0, 68788-8763-01
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-01-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Dexamethasone Tablets, USPPreferred Pharmaceuticals Inc.2026-01-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8763-0Dexamethasone100 in 1 BOTTLETABLET1002
68788-8763-1Dexamethasone12 in 1 BOTTLETABLET122
68788-8763-2Dexamethasone21 in 1 BOTTLETABLET212
68788-8763-3Dexamethasone30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8763DEXAMETHASONE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20241113_64577454-d49e-4180-99e6-8461f74b0221.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8763-0EA - Each68788-876373b37d2c-7deb-428c-966c-e729ce80b51812025-02-10
68788-8763-1EA - Each68788-87632cbcf06f-719b-4db2-87d1-69b48817d90412025-02-10
68788-8763-2EA - Each68788-8763bd7d0917-7dfc-4946-9fe8-091d2e72eb0012025-02-10
68788-8763-3EA - Each68788-87634e9107e1-bc1f-41cb-b0d3-9f5bef02d97312025-02-10

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 3 of 11 · 210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepacke830be9d-0a8c-4712-93c6-284c208d6f0d2026-02-05Warnings, Adverse reactionsExact identifier
application number: ANDA216282
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
application number: ANDA216282
ndc (package): 68788-8763-2
ndc (package): 68788-8763-1
ndc (package): 68788-8763-3
ndc (package): 68788-8763-0
ndc (product): 68788-8763
ndc11 (package): 68788876301
rxcui: 343033
spl id: 86f71920-d9ff-41d1-a70e-b90c446f6db6
spl set id: 64577454-d49e-4180-99e6-8461f74b0221
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
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
DEXAMETHASONEDEXAMETHASONEBryant Ranch Prepack075717e3-be2a-4bb3-bead-492761bfb2872026-01-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
HemadyDEXAMETHASONEEdenbridge Pharmaceuticals LLC.6b9cf32c-6d60-4853-bbfd-2304ffc2c1292026-01-09Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Anti-Smoking II Drops 2008ANTI-SMOKING II DROPSProfessional Complementary Health Formulas8e64a0eb-4673-42e3-8387-7248d38557872026-01-08WarningsExact identifier
unii: C151H8M554
Large Intestine Formula 2103LARGE INTESTINE FORMULAProfessional Complementary Health Formulas532eb4c6-0f3f-4853-89e2-43168e118d652026-01-08WarningsExact identifier
unii: XM0M87F357
Substance Abuse Drops 2063SUBSTANCE ABUSE DROPSProfessional Complementary Health Formulas61f8263d-6f72-442f-a09e-57daf7226cc72026-01-08WarningsExact identifier
unii: C151H8M554
Anti-Smoking I Drops 2007ANTI-SMOKING I DROPSProfessional Complementary Health Formulas1c6b5b98-971d-442a-b9eb-37f65409a5212026-01-08WarningsExact identifier
unii: C151H8M554
Glucose Drops 2031GLUCOSE DROPSProfessional Complementary Health Formulas21de3b86-be2b-4f71-9384-78ebc42ec0872026-01-08WarningsExact identifier
unii: C151H8M554
Geopathic Stress Drops 2096GEOPATHIC STRESS DROPSProfessional Complementary Health Formulas7d7302b8-3959-4e1e-ad1f-88d265ba9d322026-01-08WarningsExact identifier
unii: XM0M87F357
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEA-S Medication Solutionsadcc540e-9275-4a7c-918a-36fa2314acd22026-01-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONERedpharm Drug2fd20fcb-222c-bd38-e063-6294a90ac9cd2025-12-27Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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