FDA.reportPublic FDA data

acetazolamide

Product NDC
23155-287
11-digit product format
231550287
Labeler code
23155
Product ID
23155-287_d5f7fb75-ef4b-4d7b-a9d6-c4ff08920973
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA205530
Marketing category
ANDA
Marketing start
2016-10-27
Substance
ACETAZOLAMIDE
Active strength
125 mg/1
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acetazolamide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAZOLAMIDE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui197303, 197304

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94b5d997-68ee-d92e-7c04-a34fdb427a66Product name920240509
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
23155-287-012020-03-19C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetazolamide Tablets USP Rx only
23155-287-012020-03-19C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetaZOLAMIDE Tablets, USP Rx only
23155-287-102020-03-19C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetazolamide Tablets USP Rx only
23155-287-102020-03-19C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetaZOLAMIDE Tablets, USP Rx only
23155-287-012020-01-31C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetazolamide Tablets USP Rx only
23155-287-012020-01-31C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetaZOLAMIDE Tablets, USP Rx only
23155-287-102020-01-31C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetazolamide Tablets USP Rx only
23155-287-102020-01-31C16284748780-19d75b9d0-7d95-f424-e053-dadaa90a57ceAcetaZOLAMIDE Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-287-01acetazolamide100 in 1 BOTTLETABLET10011
23155-287-10acetazolamide1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-287-01EA - Each23155-287ecb3d3d1-7a56-4c24-b5c1-1e3266a4dc9912017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-287ACETAZOLAMIDE TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]9Current NDC, Legacy NDC, 2 package rows20230725_0700a910-79aa-4431-aecf-637fe14fcae8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN07fd0bde-8f7c-47d2-9e81-2c1eee259fa612
197303acetazolamide 125 MG Oral TabletSCD07fd0bde-8f7c-47d2-9e81-2c1eee259fa612
197303acetaZOLAMIDE 125 MG Oral TabletPSN0700a910-79aa-4431-aecf-637fe14fcae811
197304acetaZOLAMIDE 250 MG Oral TabletPSN0700a910-79aa-4431-aecf-637fe14fcae811
197303acetazolamide 125 MG Oral TabletSCD0700a910-79aa-4431-aecf-637fe14fcae811
197304acetazolamide 250 MG Oral TabletSCD0700a910-79aa-4431-aecf-637fe14fcae811
197303acetaZOLAMIDE 125 MG Oral TabletPSNd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197304acetaZOLAMIDE 250 MG Oral TabletPSNd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197303acetazolamide 125 MG Oral TabletSCDd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197304acetazolamide 250 MG Oral TabletSCDd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197303acetaZOLAMIDE 125 MG Oral TabletPSNf8232eaf-e108-aa00-e053-6394a90aede42
197303acetazolamide 125 MG Oral TabletSCDf8232eaf-e108-aa00-e053-6394a90aede42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-287-0123155028701100 TABLET in 1 BOTTLE (23155-287-01) 100 tablet2016-10-270000-00-00NoNoCurrent
23155-287-10231550287101000 TABLET in 1 BOTTLE (23155-287-10) 1000 tablet2016-10-270000-00-00NoNoCurrent