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 7 of 8 · 158 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited1e84a609-22a0-41b9-83a0-c45019c8cf9a2024-03-30Exact identifier
rxcui: 197581
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEZydus Lifesciences Limited522a1a49-5540-4245-a15f-e3cdc0a97a5e2024-03-30Exact identifier
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEViona Pharmaceuticals Inc86afd383-7d6b-48f0-a803-9446fa1ded102024-03-29Warnings, Adverse reactionsExact identifier
rxcui: 197581
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEChartwell RX, LLC3746066a-3c87-4238-945a-6dfb4d01a0722024-03-14Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONENorthStar Rx LLC05c77a4c-c508-babd-e063-6294a90a450a2024-03-08Warnings, Adverse reactionsExact identifier
application number: ANDA215604
ndc (product): 72603-189
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
rxcui: 197581
spl id: 132845af-9ab6-2327-e063-6294a90a6673
spl set id: 05c77a4c-c508-babd-e063-6294a90a450a
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEANI Pharmaceuticals, Inc.fe8cf911-84ef-47be-acb8-0501b546299b2024-03-04Warnings, Adverse reactionsExact identifier
application number: ANDA215604
rxcui: 343033
rxcui: 197577
rxcui: 197582
rxcui: 197580
rxcui: 197583
rxcui: 197581
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEAmneal Pharmaceuticals NY LLCac71f888-c83a-46a5-921c-1ebdf6cfadc12024-02-21Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
dexamethasoneDEXAMETHASONEAmneal Pharmaceuticals NY LLCb9eb9a30-c1da-4d38-8ea8-616a254e2afc2024-02-21Warnings, Adverse reactionsExact identifier
rxcui: 197581
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEAlvogen Inc.9ab26af9-8196-e3d3-76a3-75227fd4e1c32024-02-21Warnings, Adverse reactionsExact identifier
rxcui: 197582
rxcui: 197583
unii: 7S5I7G3JQL
Neo/Poly-B/Dex Ophth OintNEO/POLY-B/DEX OPHTH OINTDirect_Rx0ec1dfdf-b63f-fb0c-e063-6294a90a843d2024-01-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepacka5f0b05b-3dec-4fe8-8106-e41e668a512d2024-01-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack3c63c481-ce57-41ca-993f-5a5b665fa1e42024-01-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DEXAMETHASONEDEXAMETHASONEDirect Rx3ff06262-4c6f-4423-99fa-b4d8191ea1332024-01-09Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
Dexamethasone 1.5 mgDEXAMETHASONE 1.5 MGProficient Rx LP42db0356-3948-444c-bda3-1226b4ca89852024-01-01Warnings, Adverse reactionsExact identifier
rxcui: 197580
unii: 7S5I7G3JQL
MAXITROLNEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONESandoz Inc5776c435-ac60-49b6-8db1-23a3012b91552023-12-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and dexamethasoneCIPROFLOXACIN AND DEXAMETHASONEARMAS PHARMACEUTICALS INC.eed6b293-6bbe-4bd3-ad9d-3849e0eb6c052023-11-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Neomycin and Polymyxin B Sulfates and DexamethasoneNEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONEA-S Medication Solutions0d273133-0ce9-4fe6-b873-7f85aac254862023-11-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
unii: H3R47K3TBD
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: H3R47K3TBD

Reported adverse events (FAERS/openFDA)#

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