Acetazolamide

Product NDC
81005-105
11-digit product format
810050105
Labeler code
81005
Product ID
81005-105_45753e50-34f0-97e1-e063-6394a90abd3d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Aarkish Pharmaceuticals NJ Inc.
Application
ANDA217197
Marketing category
ANDA
Marketing start
2024-12-03
Substance
ACETAZOLAMIDE
Active strength
250 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
ACETAZOLAMIDE250 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
81005-105-01Acetazolamide100 in 1 BOTTLETABLET1008
81005-105-10Acetazolamide1000 in 1 BOTTLETABLET10008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81005-105ACETAZOLAMIDE TABLET [AARKISH PHARMACEUTICALS NJ INC.]6Current NDC, 2 package rows20241215_ddfd44dc-3136-4dda-8ed0-eb2991c2a0b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNddfd44dc-3136-4dda-8ed0-eb2991c2a0b68
197304acetaZOLAMIDE 250 MG Oral TabletPSNddfd44dc-3136-4dda-8ed0-eb2991c2a0b68
197303acetazolamide 125 MG Oral TabletSCDddfd44dc-3136-4dda-8ed0-eb2991c2a0b68
197304acetazolamide 250 MG Oral TabletSCDddfd44dc-3136-4dda-8ed0-eb2991c2a0b68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81005-105-0181005010501100 TABLET in 1 BOTTLE (81005-105-01) 100 tablet2024-12-03NoNoHistorical
81005-105-10810050105101000 TABLET in 1 BOTTLE (81005-105-10) 1000 tablet2024-12-03NoNoHistorical