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 5 of 11 · 210 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals5ec5b0e6-7fa8-4afc-97a4-d185484ada8b2025-09-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONERising Pharma Holdings, Inc.7cf5c17c-a80b-4547-83b2-0d53e2b933f72025-09-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONEPreferred Pharmaceuticals, Inc.449a6fd8-c2ac-40d0-b74a-e5c7fc6670f32025-08-18Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEA-S Medication Solutions16c59e9a-8e4f-4300-bbbb-bcc982c18fc82025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEA-S Medication Solutions89af5591-eebf-44e7-827f-ce3b123123e42025-08-15Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENuCare Pharmaceuticals,Inc.141e16a7-1f3d-3943-e063-6294a90ac5a92025-07-30Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
Aller-Chord FACETALDEHYDE, ACETICUM AC, ARG NIT, CAFFEINUM, CALC SULPH, CITRICUM AC, CORTISONE ACETICUM, ECHINACEA PURP, FOLLICULINUM, FRAGARIA, FUMARICUM AC, GALLICUM AC, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, HYDRANGEA, LAC VAC, LECITHIN, LIMULUS, LYCOPERSICUM, LYCOPODIUM, NAT BICARB, NAT MUR, NUX VOM, PARAFFINUM, PHOSPHORICUM AC, SACCHARUM OFF, SILICEA, TARTARICUM AC, TORULA CEREVISIAE.Energetix Corporationff4eb7b2-8272-4bd3-99a9-7e589b30d59a2025-07-15WarningsExact identifier
unii: C151H8M554
Dexamethasone IntensolDEXAMETHASONE INTENSOLHikma Pharmaceuticals USA, Inc.b15200fb-1826-472b-a907-e677a272513b2025-06-06Warnings, Adverse reactionsExact identifier
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
unii: 7S5I7G3JQL
IntimateANACARDIUM ORIENTALE, AURUM MURIATICUM NATRONATUM, CAMPHORA, DNA (HUMAN), GERMANIUM METALLICUM, HELLEBORUS NIGER, HYDROGEN, LAC CANINUM, LAC MATERNA HUMANUM, LITHIUM CARBONICUM, MAGNESIA OXYDATA, NATRUM CARBONICUM, NEON, OXYTOCIN, PLACENTA TOTALIS SUIS, RHUS GLABRA, SACCHARUM OFFICINALE, STRAMONIUM, THUJA OCCIDENTALISDeseret Biologicals, Inc.066bd402-378b-48aa-9515-188c261a3f4c2025-05-27WarningsExact identifier
unii: C151H8M554
ShameADRENALINUM, AGNUS CASTUS, ALOE, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, BARYTA CARBONICA, CALCAREA IODATA, CANDIDA ALBICANS, CEREBRUM SUIS, CINCHONA OFFICINALIS, DIGITALIS PURPUREA, HYPOTHALAMUS SUIS, IGNATIA AMARA, LAC DEFLORATUM, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, RHUS GLABRA, SACCHARUM OFFICINALE, SEROTONIN (HYDROCHLORIDE), STAPHYSAGRIA, THUJA OCCIDENTALISDeseret Biologicals, Inc.090e4a23-3e1b-4b0c-a0cc-0172b05f7b642025-05-07WarningsExact identifier
unii: C151H8M554
DexamethasoneDEXAMETHASONEAdvanced Rx of Tennessee, LLC348f5a56-978d-4272-e063-6294a90afdb62025-05-07Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
MAXIDEXDEXAMETHASONEHarrow Eye, LLC35e47fcd-e020-43e5-8322-41f8060d220d2025-05-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.a5609df4-4933-4f85-a7b8-bc54a70a2bac2025-04-30Warnings, Adverse reactionsExact identifier
application number: ANDA216282
rxcui: 343033
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEMarlex Pharmaceuticals, Inc7b51ffce-ec64-4b49-8870-b9666537c5412025-04-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXTENZADEXAMETHASONEOcular Therapeutix, Inc.7514e6b8-c33f-4fbf-8810-ef520e1eb4bd2025-04-18Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONENEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPSDirectRxd5e00bad-abb4-63ad-e053-2a95a90a5abb2025-04-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESandoz Inc05fd0c36-39b4-4a43-8490-eb8dfc0920ae2025-04-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobradex STTOBRAMYCIN / DEXAMETHASONEHarrow Eye, LLC3b99dbb3-ac84-4d0d-b30f-a5db44fdc3162025-04-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEProficient Rx LP3f2fe98a-ab42-4bec-bf97-c090567f9ad62025-04-01Warnings, Adverse reactionsExact identifier
rxcui: 197582
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBionpharma Inc.,401ec088-984a-49ab-b317-747c2b9b9e222025-03-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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