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 8 of 11 · 210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEBryant Ranch Prepack710ce0fc-78b3-402d-a2ca-e5eda09f32112024-06-11Warnings, Adverse reactionsExact identifier
rxcui: 343033
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONEA-S Medication Solutions6791e6c3-514d-4b98-8887-ca2b894576b52024-06-10Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONENuCare Pharmaceuticals,Inc.691bc5ca-5d61-60c2-e053-2991aa0abb932024-06-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONENuCare Pharmaceuticals,Inc.61693e79-81d1-3162-e053-2a91aa0ae9252024-06-06Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONEDr. Reddy's Laboratories, Inc.f07cf7d6-c233-884e-342d-c6c8cd2c84382024-05-30Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBryant Ranch Prepackc75360d3-2e4f-4620-a8f0-db28b1aa704b2024-05-28Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
AllergiesAPIS MELLIFICA, ECHINACEA, HYDRASTIS CANADENSIS, TARAXACUM OFFICINALE, ACONITUM NAPELLUS, AETHUSA CYNAPIUM, AGARICUS MUSCARIUS, ALETRIS FARINOSA, ALFALFA, ALLIUM CEPA, ALLIUM SATIVUM, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, ARTEMISIA VULGARIS, ARUNDO MAURITANICA, AVENA SATIVA, BELLADONNA, BELLIS PERRENIS, BOVISTA, BROMIUM, BRYONIA, CAFFEINUM, CALCAREA CARBONICA, CALLUNA VULGARIS, FLOS, CAPSICUM ANNUUM, CAT HAIR, CHAMOMILLA, CHELIDONIUM MAJUS, CHENOPODIUM ANTHELMINTICUM, CINNAMOMUMNewton Laboratories, Inc.9d5dea47-5103-21a3-e053-2995a90aee782024-05-20WarningsExact identifier
unii: C151H8M554
DexamethasoneDEXAMETHASONEZydus Lifesciences Limitede9012a11-6219-4272-aea2-b7328bbcf5232024-05-13Exact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc360d3af0-8f69-4e82-ab5f-1f70cc2025d42024-05-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
IntimateNATRUM CARBONICUM, SACCHARUM OFFICINALE, LITHIUM CARBONICUM, PLACENTA TOTALIS SUIS, LAC CANINUM, ANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, GERMANIUM METALLICUM, HELLEBORUS NIGER, MAGNESIA OXYDATA, RHUS GLABRA, STRAMONIUM, THUJA OCCIDENTALIS, DNA (HUMAN), OXYTOCIN, HYDROGEN, NEON, LAC MATERNA HUMANUMDeseret Biologicals, Inc.ca0447c1-606e-443a-b789-7d65143fec282024-05-13WarningsExact identifier
unii: C151H8M554
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.17f56402-331e-2e3d-e063-6394a90acc0e2024-05-08Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
GlyregACETICUM ACIDUM, CACAO, MAGNESIA SULPHURICA, NATRUM SULPHURICUM, VERBASCUM THAPSUS, GLANDULA SUPRARENALIS SUIS, PANCREAS SUIS, CORTISONE ACETICUM, THYROIDINUM (SUIS), IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORUS, RANUNCULUS BULBOSUS, SACCHARUM OFFICINALE, VANADIUM METALLICUM, ZINCUM METALLICUM, CHROMIUM ACIDUM, CULEX MUSCADeseret Biologicals, Inc28e670ca-ed35-4256-af20-74c25dc180992024-04-23WarningsExact identifier
unii: C151H8M554
DexamethasoneDEXAMETHASONEBryant Ranch Prepack36f104ba-80b4-4713-aa74-f80483b7bded2024-04-03Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc93bb34a7-c8ca-4dab-b2a0-cbe011e1090c2024-03-30Warnings, Adverse reactionsExact identifier
application number: ANDA216282
ndc (product): 72578-169
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
spl id: 0b2ad1c2-aa4a-4741-ae0b-645a3943dd77
spl set id: 93bb34a7-c8ca-4dab-b2a0-cbe011e1090c
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited1e84a609-22a0-41b9-83a0-c45019c8cf9a2024-03-30Exact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited522a1a49-5540-4245-a15f-e3cdc0a97a5e2024-03-30Exact identifier
application number: ANDA216282
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc86afd383-7d6b-48f0-a803-9446fa1ded102024-03-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
HabitCHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUSDeseret Biologicals, Inc.3d00a305-e15d-4419-97bd-332421d4a1b02024-03-15WarningsExact identifier
unii: C151H8M554
DexamethasoneDEXAMETHASONEChartwell RX, LLC3746066a-3c87-4238-945a-6dfb4d01a0722024-03-14Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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