acetazolamide

Product NDC
60687-578
11-digit product format
606870578
Labeler code
60687
Product ID
60687-578_365ff016-96db-785d-e063-6394a90aaada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
CAPSULE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA205301
Marketing category
ANDA
Marketing start
2020-10-27
Substance
ACETAZOLAMIDE
Active strength
500 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
ACETAZOLAMIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui562524

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
94b5d997-68ee-d92e-7c04-a34fdb427a66Product name920240509
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-578-11acetazolamide1 in 1 BLISTER PACKCAPSULE15
60687-578-21acetazolamide30 in 1 BOX, UNIT-DOSECAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-578ACETAZOLAMIDE CAPSULE [AMERICAN HEALTH PACKAGING]4Current NDC, Legacy NDC, 2 package rows20241024_4e8797d9-2e78-49e0-af25-ac5d1f792499.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN4e8797d9-2e78-49e0-af25-ac5d1f7924995
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD4e8797d9-2e78-49e0-af25-ac5d1f7924995
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY4e8797d9-2e78-49e0-af25-ac5d1f7924995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60687-578-11606870578111 in 1 BLISTER PACKHistorical
60687-578-216068705782130 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-578-21) / 1 CAPSULE in 1 BLISTER PACK (60687-578-11) 30 blister pack2020-10-270000-00-00NoNoCurrent