ACETAZOLAMIDE

Product NDC
59651-905
11-digit product format
596510905
Labeler code
59651
Product ID
59651-905_0392e11a-1290-442f-9765-e1f79ec43eae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACETAZOLAMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA212089
Marketing category
ANDA
Marketing start
2025-05-30
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
59651-905-01ACETAZOLAMIDE100 in 1 BOTTLETABLET1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-905-01EA - Each59651-90536325896-08e3-4bd6-845c-80ac8ad0b85c12025-10-14

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN513da48f-8f12-4696-b862-e8d882bf86112
197304acetaZOLAMIDE 250 MG Oral TabletPSN513da48f-8f12-4696-b862-e8d882bf86112
197303acetazolamide 125 MG Oral TabletSCD513da48f-8f12-4696-b862-e8d882bf86112
197304acetazolamide 250 MG Oral TabletSCD513da48f-8f12-4696-b862-e8d882bf86112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-905-0159651090501100 TABLET in 1 BOTTLE (59651-905-01) 100 tablet2025-05-30NoNoHistorical