FDA.reportPublic FDA data

NDC 68071-3588-01 - 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
68071-3588
Requested NDC
68071-3588-01
Package NDCs from labels
68071-3588-6, 68071-3588-1, 68071-3588-8, 68071-3588-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2025-07-30
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.2025-07-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3588-1Dexamethasone10 in 1 BOTTLETABLET103
68071-3588-6Dexamethasone6 in 1 BOTTLETABLET63
68071-3588-8Dexamethasone8 in 1 BOTTLETABLET83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3588DEXAMETHASONE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 3 package rows20241204_141e16a7-1f3d-3943-e063-6294a90ac5a9.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 4 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGLarken Laboratories, Inc.fcc75691-974e-4a67-b9d7-64dde72b55952025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEApotex Corp.bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf22025-09-17Warnings, Adverse reactionsExact identifier
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
rxcui: 197581
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEMajor Pharmaceuticals5ec5b0e6-7fa8-4afc-97a4-d185484ada8b2025-09-08Warnings, Adverse reactionsExact identifier
rxcui: 197581
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
application number: ANDA215604
ndc (package): 68071-3588-1
ndc (package): 68071-3588-6
ndc (package): 68071-3588-8
ndc (product): 68071-3588
ndc11 (package): 68071358801
rxcui: 197582
spl id: 3b2d9344-a30a-844a-e063-6294a90ae9f4
spl set id: 141e16a7-1f3d-3943-e063-6294a90ac5a9
unii: 7S5I7G3JQL
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
rxcui: 197581
unii: 7S5I7G3JQL
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
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
rxcui: 197581
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEBionpharma Inc.,3166db4f-66a5-496a-a194-3cc01b7347d32025-03-05Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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