acetazolamide

Product NDC
0904-6663
11-digit product format
009046663
Labeler code
0904
Product ID
0904-6663_6ac9aecc-c4b1-4fd4-88c0-2d83cf584743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA205530
Marketing category
ANDA
Marketing start
2013-03-15
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

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
0904-6663-61acetazolamide1 in 1 BLISTER PACKTABLET17
0904-6663-61acetazolamide100 in 1 CARTONTABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6663-61EA - Each0904-666317d73267-24c1-4275-9654-f67c7d5846c512019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6663ACETAZOLAMIDE TABLET [MAJOR PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20250402_37135ba5-63fd-427f-9b4a-8b7d1009bbca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197304acetaZOLAMIDE 250 MG Oral TabletPSN37135ba5-63fd-427f-9b4a-8b7d1009bbca7
197304acetazolamide 250 MG Oral TabletSCD37135ba5-63fd-427f-9b4a-8b7d1009bbca7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6663-6100904666361100 BLISTER PACK in 1 CARTON (0904-6663-61) / 1 TABLET in 1 BLISTER PACK100 blister pack2013-03-150000-00-00NoNoCurrent