Acetazolamide

Product NDC
68071-3728
11-digit product format
680713728
Labeler code
68071
Product ID
68071-3728_27888b41-786a-8b5f-e063-6394a90adb98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticlas, Inc.
Application
ANDA209734
Marketing category
ANDA
Marketing start
2017-11-20
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

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
68071-3728-1Acetazolamide12 in 1 BOTTLETABLET121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3728ACETAZOLAMIDE TABLET [NUCARE PHARMACEUTICLAS, INC.]1Current NDC, 1 package rows20241124_278878bc-da9c-09d4-e063-6394a90abaf7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN278878bc-da9c-09d4-e063-6394a90abaf71
197303acetazolamide 125 MG Oral TabletSCD278878bc-da9c-09d4-e063-6394a90abaf71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3728-16807137280112 TABLET in 1 BOTTLE (68071-3728-1) 12 tablet2024-11-22NoNoCurrent