FDA.reportPublic FDA data

NDC 70382-204-88 - DEXTENZA

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
70382-204
Requested NDC
70382-204-88
Package NDCs from labels
70382-204-88, 70382-204-01, 70382-204-10, 70382-204-99
Manufacturer
Ocular Therapeutix, Inc. | Isomedix Operations, Steris Corporation | Packaging Coordinators, Inc. | Pharmacia & Upjohn Company LLC
Effective date
2025-04-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
DEXTENZAOcular Therapeutix, Inc. | Isomedix Operations, Steris Corporation | Packaging Coordinators, Inc. | Pharmacia & Upjohn Company LLC2025-04-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70382-204-01DEXTENZA1 in 1 BOX, UNIT-DOSEINSERT118
70382-204-10DEXTENZA10 in 1 BOX, UNIT-DOSEINSERT1018
70382-204-88DEXTENZA1 in 1 POUCHINSERT118
70382-204-99DEXTENZA1 in 1 BOX, UNIT-DOSEINSERT118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70382-204DEXTENZA (DEXAMETHASONE) INSERT [OCULAR THERAPEUTIX, INC. ]17Current NDC, Legacy NDC, 4 package rows20250420_7514e6b8-c33f-4fbf-8810-ef520e1eb4bd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70382-204-01EA - Each70382-204d29a4426-4bb4-44ac-84cd-975d682804fd12019-01-24
70382-204-10EA - Each70382-204dc77240e-dad4-4b2f-8fa0-a5b899dd007f12019-01-24

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 1 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8c5375a7-7a0d-4af0-8b86-bc87698ac3d12026-09-04Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Dexamethasone IntensolDEXAMETHASONE INTENSOLSportpharm LLC77429dd3-e66d-4ab4-a3f3-5ae0b987ac172026-08-21Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TobraDexTOBRAMYCIN AND DEXAMETHASONENovartis Pharmaceuticals Corporation7f310e0e-0d3b-493d-b6c4-238493a2a9b92026-07-22Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONESportpharm LLCa37486b9-4323-41fc-ac7e-869d95dc95682026-07-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONESportpharm LLC780a5554-54ef-4294-b681-8c5300b028b62026-07-13Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.f5c9b70b-b835-4f3b-9643-0aec50a0d3f22026-07-07Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONESportpharm LLCfa3d2fda-6857-4ef1-8dae-a2877f7569af2026-07-02Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPangea Pharmaceuticals, LLCa41e6e26-9ebb-4b06-866e-a24af21c644c2026-06-29Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Ciprofloxacin and DexamethasoneCIPROFLOXACIN AND DEXAMETHASONERedpharm Drug546bf602-4b4c-cb08-e063-6394a90a2c552026-06-17Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.89e1d458-7caa-430f-9c54-360889899a732026-06-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPD-Rx Pharmaceuticals, Inc.736861fa-1df8-4afd-ba4a-dd7d7bffd8652026-06-12Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Tobramycin and DexamethasoneTOBRAMYCIN AND DEXAMETHASONEREMEDYREPACK INC.c606945c-4ffc-4ee8-af04-a00de8ea92592026-06-11Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEPreferred Pharmaceuticals Inc79b65fd4-16a5-42e0-b041-61d7bda0a5ff2026-06-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepackdf4a7747-8dfa-4933-b4d2-a3d85c5f74f82026-06-08Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONEREMEDYREPACK INC.8deaaaf7-3efd-4065-b29f-e5ef038030f82026-06-01Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
TOBRAMYCIN AND DEXAMETHASONETOBRAMYCIN AND DEXAMETHASONEBryant Ranch Prepack1884ef6f-a60c-4a82-a7dc-fd48b7176db02026-05-28Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONECardinal Health 107, LLCbf8acfdb-8dc8-4a69-90b0-33c680c421d62026-05-15Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
Sodium PhosphatesSODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUSHospira, Inc.6f044d16-295e-43ff-72a3-b045c387bc5c2026-05-11Warnings, Adverse reactionsExact identifier
unii: 22ADO53M6F
dexamethasoneDEXAMETHASONECardinal Health 107, LLC5622f8d2-1893-441b-8011-fa90c8a63b0b2026-05-05Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL
DexamethasoneDEXAMETHASONESportpharm LLC12d19271-867b-41ae-a6d2-7e8de36370112026-04-24Warnings, Adverse reactionsExact identifier
unii: 7S5I7G3JQL

Reported adverse events (FAERS/openFDA)#

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