FDA.reportPublic FDA data

acetazolamide

Product NDC
50090-5617
11-digit product format
500905617
Labeler code
50090
Product ID
50090-5617_120056fe-47c8-4cac-9450-0ed12e14b489
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

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
50090-5617-02023-02-07C16284748780-1f386c649-c506-0266-e053-dadaa90a7c1aAcetazolamide Tablets USP Rx only
50090-5617-12023-02-07C16284748780-1f386c649-c506-0266-e053-dadaa90a7c1aAcetazolamide Tablets USP Rx only
50090-5617-02023-01-30C16284748780-1f386c649-c506-0266-e053-dadaa90a7c1aAcetazolamide Tablets USP Rx only
50090-5617-12023-01-30C16284748780-1f386c649-c506-0266-e053-dadaa90a7c1aAcetazolamide Tablets USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5617-0acetazolamide100 in 1 BOTTLETABLET10012
50090-5617-1acetazolamide12 in 1 BOTTLETABLET1212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5617ACETAZOLAMIDE TABLET [A-S MEDICATION SOLUTIONS]10Current NDC, Legacy NDC, 2 package rows20240606_07fd0bde-8f7c-47d2-9e81-2c1eee259fa6.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5617-050090561700100 TABLET in 1 BOTTLE (50090-5617-0) 100 tablet2021-08-230000-00-00NoNoCurrent
50090-5617-15009056170112 TABLET in 1 BOTTLE (50090-5617-1) 12 tablet2021-08-230000-00-00NoNoCurrent