FDA.reportPublic FDA data

ACETAZOLAMIDE

Product NDC
52817-200
11-digit product format
528170200
Labeler code
52817
Product ID
52817-200_1df8bd81-54fe-44ea-98aa-5f13592dd8bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAZOLAMIDE
Dosage form
TABLET
Route
ORAL
Labeler
TRUPHARMA, LLC
Application
ANDA211372
Marketing category
ANDA
Marketing start
2021-04-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ACETAZOLAMIDE
Listing expiration
2026-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52817-200-00ACETAZOLAMIDE1000 in 1 BOTTLE, PLASTICTABLET10006
52817-200-10ACETAZOLAMIDE100 in 1 BOTTLE, PLASTICTABLET1006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-200-10EA - Each52817-20009769fc8-6898-4fa0-8695-9d19ee72a4e712021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-200ACETAZOLAMIDE TABLET [TRUPHARMA, LLC]6Current NDC, Legacy NDC, 2 package rows20220717_4fcd428a-7bf3-4e75-a834-1bdf1078107f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN4fcd428a-7bf3-4e75-a834-1bdf1078107f6
197304acetaZOLAMIDE 250 MG Oral TabletPSN4fcd428a-7bf3-4e75-a834-1bdf1078107f6
197303acetazolamide 125 MG Oral TabletSCD4fcd428a-7bf3-4e75-a834-1bdf1078107f6
197304acetazolamide 250 MG Oral TabletSCD4fcd428a-7bf3-4e75-a834-1bdf1078107f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52817-200-00528170200001000 TABLET in 1 BOTTLE, PLASTIC (52817-200-00) 1000 tablet2021-06-010000-00-00NoNoCurrent
52817-200-1052817020010100 TABLET in 1 BOTTLE, PLASTIC (52817-200-10) 100 tablet2021-06-010000-00-00NoNoCurrent