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 1 of 3 · 53 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDEStrides Pharma Science Limited4813b9dd-5f58-44bb-ad64-cdb3318280802026-08-19Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEPD-Rx Pharmaceuticals, Inc.268db224-d5db-457c-86bc-972c9fe079172026-07-07Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEMajor Pharmaceuticals37135ba5-63fd-427f-9b4a-8b7d1009bbca2026-05-28Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEA-S Medication Solutionsc5acf531-ba55-47b7-88db-e5da0206ebf12026-05-22Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack71f1fbbb-428e-4bf7-bc20-2946c1079bd32026-05-20Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.0700a910-79aa-4431-aecf-637fe14fcae82026-05-12Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEA-S Medication Solutions07fd0bde-8f7c-47d2-9e81-2c1eee259fa62026-05-01Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEREMEDYREPACK INC.fb2cf8fe-da81-445e-a18b-9aa9ced1d34a2026-04-28Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
acetazolamideACETAZOLAMIDEBryant Ranch Prepack0d903375-c583-4362-9f8a-f7b74ce01e0b2026-04-09Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack9af15152-d46f-4bc3-a16e-b70a472bc52a2026-03-23Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEBryant Ranch Prepack84a582a9-c7e5-4159-a5eb-a47a96b4afc02026-03-23Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEBryant Ranch Prepackf7227cc5-0a80-47df-baf8-09f1b22b187e2026-03-20Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDELifestar Pharma LLC0913db35-3f08-4d82-8394-486bd9a487c42026-03-17Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.33d912ea-9e1c-49eb-bd93-f0b1b2da67b62026-02-26Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEAvKAREd6fba129-ac6e-4d04-bd09-8470be4e7ecc2026-02-24Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEWestminster Pharmaceuticals, LLC417b1df2-63bc-473c-9e02-5f93dd45554d2026-02-17Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetaZOLAMIDEACETAZOLAMIDEA-S Medication Solutionsb339843f-0324-4996-88a0-0619fd6f867b2026-02-13Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEMarlex Pharmaceuticals, Inc.4a03f35d-bfcb-77ff-e063-6294a90a4f062026-02-01Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I

Reported adverse events (FAERS/openFDA)#

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