FDA.reportPublic FDA data

Acetazolamide

Product NDC
64380-834
11-digit product format
643800834
Labeler code
64380
Product ID
64380-834_69be4b8b-13c5-48f6-8c8b-58b7879152c0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Strides Pharma Science Limited
Application
ANDA209734
Marketing category
ANDA
Marketing start
2017-11-20
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
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64380-834-062024-02-27C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-062024-02-27C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-462024-02-27C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-462024-02-27C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-062024-01-30C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-062024-01-30C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-462024-01-30C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP
64380-834-462024-01-30C16284748780-11030e365-65f7-111a-e063-dadaa90a10e2AcetaZOLAMIDE Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64380-834-06Acetazolamide100 in 1 BOTTLETABLET10010
64380-834-46Acetazolamide1000 in 1 BAGTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
64380-834-06EA - Each64380-834eae42124-5285-4c5d-80e9-2fdef9a03bf712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64380-834ACETAZOLAMIDE TABLET [STRIDES PHARMA SCIENCE LIMITED]7Current NDC, Legacy NDC, 2 package rows20250129_4813b9dd-5f58-44bb-ad64-cdb331828080.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN4813b9dd-5f58-44bb-ad64-cdb33182808010
197304acetaZOLAMIDE 250 MG Oral TabletPSN4813b9dd-5f58-44bb-ad64-cdb33182808010
197303acetazolamide 125 MG Oral TabletSCD4813b9dd-5f58-44bb-ad64-cdb33182808010
197304acetazolamide 250 MG Oral TabletSCD4813b9dd-5f58-44bb-ad64-cdb33182808010
197304acetaZOLAMIDE 250 MG Oral TabletPSNe9152bc5-5817-4a6a-9d2a-0dd77074f5015
197304acetazolamide 250 MG Oral TabletSCDe9152bc5-5817-4a6a-9d2a-0dd77074f5015
197304acetaZOLAMIDE 250 MG Oral TabletPSNa9dca448-5511-413e-e053-2a95a90a8c664
197304acetazolamide 250 MG Oral TabletSCDa9dca448-5511-413e-e053-2a95a90a8c664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64380-834-0664380083406100 TABLET in 1 BOTTLE (64380-834-06) 100 tablet2017-11-200000-00-00NoNoCurrent
64380-834-46643800834461000 TABLET in 1 BAG (64380-834-46) 1000 tablet2017-11-200000-00-00NoNoCurrent