FDA.reportPublic FDA data

NDC 68084-541-11 - AcetaZOLAMIDE

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
68084-541
Requested NDC
68084-541-11
Package NDCs from labels
68084-541-11, 68084-541-01
Manufacturer
American Health Packaging
Effective date
2022-05-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AcetaZOLAMIDE - American Health PackagingAmerican Health Packaging2022-05-06HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-541-01EA - Each68084-541b7d235da-99c9-4791-8083-928f7e89056a12012-07-24
68084-541-11EA - Each68084-54165d92ce4-8127-4bc6-ac2d-82bc51ff1b3b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAZOLAMIDEACTIVE INGREDIENTO3FX965V0IACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
ACETAZOLAMIDEACTIVE MOIETYO3FX965V0IACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAZOLAMIDE TABLET [AMERICAN HEALTH PACKAGING]2

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 2 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDEANI Pharmaceuticals, Inc.bde94a48-05d0-45a0-a589-ec05b7d165322026-01-23Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
AcetazolamideACETAZOLAMIDEAvPAKa9dca448-5511-413e-e053-2a95a90a8c662026-01-08Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEPD-Rx Pharmaceuticals, Inc.c525ef20-ec9a-4ffd-b5ea-e53c186fe7162026-01-05Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDENorthwind Health Company, LLCf8232eaf-e108-aa00-e053-6394a90aede42026-01-01Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
acetazolamideACETAZOLAMIDEAccord Healthcare Inc.9a368b35-cd51-47ad-83cc-ccc56c4585e82025-12-15Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
ACETAZOLAMIDE EXTENDED-RELEASEACETAZOLAMIDE EXTENDED-RELEASEMicro Labs Limited78f78919-a6ba-4072-bc45-2ab3637ed8942025-12-08Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEAarkish Pharmaceuticals NJ Inc.ddfd44dc-3136-4dda-8ed0-eb2991c2a0b62025-12-08Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEEywa Pharma Incc19166fa-2cef-4c96-a956-ea540a8ba9c32025-12-05Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEIngenus Pharmaceuticals, LLCa1f6ed35-9188-4115-8a3c-1ac91c07bf7d2025-12-05Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEAdvagen Pharma Ltdc24d31f0-a556-4e53-97a9-4e05e28ca40f2025-11-12Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
ACETAZOLAMIDEACETAZOLAMIDEAurobindo Pharma Limited513da48f-8f12-4696-b862-e8d882bf86112025-11-03Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetaZOLAMIDEACETAZOLAMIDEViona Pharmaceuticals Inc5473c171-dc2d-4a82-bbf1-0f5fad10f6732025-11-03Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetaZOLAMIDEACETAZOLAMIDEZydus Lifesciences Limiteddf84fea3-8947-403f-b470-1eeb6c4c293d2025-10-31Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEAmerican Health Packaging4e8797d9-2e78-49e0-af25-ac5d1f7924992025-05-30Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDENuCare Pharmaceuticals,Inc.0b76c194-b244-e9ac-e063-6394a90a373e2025-02-03Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDENuCare Pharmaceuticlas, Inc.278878bc-da9c-09d4-e063-6394a90abaf72024-11-22Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack923031ec-8142-4570-b3a6-210441d971052024-10-29Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEChartwell RX, LLCe8e48a25-5f6c-4b5a-a5f2-ee87aabea33b2024-10-10Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I

Reported adverse events (FAERS/openFDA)#

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