FDA.reportPublic FDA data

NDC 42291-103-90 - 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
42291-103
Requested NDC
42291-103-90
Package NDCs from labels
42291-103-10, 42291-103-90
Manufacturer
AvKARE
Effective date
2022-01-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
AcetaZOLAMIDE - AvKAREAvKARE2022-01-13HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-103-10EA - Each42291-103a522cfff-4fd9-43c1-babc-b9b72cc9bde712013-12-02
42291-103-90EA - Each42291-1038f6f5e42-45c2-4397-858e-19d280705eec12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAZOLAMIDEACTIVE INGREDIENTO3FX965V0IACETAZOLAMIDE (ACETAZOLAMIDE) TABLET [AVKARE, INC.]3
ACETAZOLAMIDEACTIVE MOIETYO3FX965V0IACETAZOLAMIDE (ACETAZOLAMIDE) TABLET [AVKARE, INC.]3
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LACETAZOLAMIDE (ACETAZOLAMIDE) TABLET [AVKARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAZOLAMIDE (ACETAZOLAMIDE) TABLET [AVKARE, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAZOLAMIDE (ACETAZOLAMIDE) TABLET [AVKARE, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAZOLAMIDE (ACETAZOLAMIDE) TABLET [AVKARE, INC.]3

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 3 of 3 · 52 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetazolamideACETAZOLAMIDEChartwell RX, LLCf75bbf55-98ac-4f91-b6fd-17b5ac860e552024-10-10Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEZydus Pharmaceuticals (USA) Inc.bf514e99-4958-44a0-a87a-02a950f87e602024-10-08Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetazolamideACETAZOLAMIDEZydus Lifesciences Limited2c1d9078-c15f-4dce-bc26-edfa5400fa9b2024-10-08Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEAlembic Pharmaceuticals Inc.43231abb-2a5d-44ab-b3e6-7564a1131ac52024-09-30Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetaZOLAMIDEACETAZOLAMIDENuCare Pharmaceuticals,Inc.1b2c973f-82ef-a4f3-e063-6394a90aaae02024-08-09Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
acetaZOLAMIDEACETAZOLAMIDEZydus Pharmaceuticals (USA) Inc.85e4d8f6-1e82-4068-a768-752287d4ccf22024-03-26Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
ACETAZOLAMIDE EXTENDED-RELEASEACETAZOLAMIDE EXTENDED-RELEASEAvPAKe43f991d-15b9-1e66-e053-2a95a90a94492024-01-09Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
e7b423e2-5bac-20a9-e053-2a95a90aa3721cb912d1-0d48-7e6f-a7b6-f766be6b86b02022-09-02Warnings, Adverse reactionsExact identifier
spl set id: 1cb912d1-0d48-7e6f-a7b6-f766be6b86b0
ACETAZOLAMIDEACETAZOLAMIDETRUPHARMA, LLC4fcd428a-7bf3-4e75-a834-1bdf1078107f2022-06-13Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEProficient Rx LP3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc2019-10-01Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I
AcetazolamideACETAZOLAMIDEAlembic Pharmaceuticals Limitedd9c1cc75-4e3d-4eaf-87c5-d5942a8438182019-02-20Warnings, Adverse reactionsExact identifier
unii: O3FX965V0I

Reported adverse events (FAERS/openFDA)#

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