Acetazolamide

Product NDC
72789-045
11-digit product format
727890045
Labeler code
72789
Product ID
72789-045_4af3a096-3d49-ebc1-e063-6294a90a6892
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
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
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
72789-045-06Acetazolamide6 in 1 BOTTLE, PLASTICTABLET611
72789-045-12Acetazolamide12 in 1 BOTTLE, PLASTICTABLET1211

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-045ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]10Current NDC, Legacy NDC, 2 package rows20250502_268db224-d5db-457c-86bc-972c9fe07917.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN268db224-d5db-457c-86bc-972c9fe0791711
197303acetazolamide 125 MG Oral TabletSCD268db224-d5db-457c-86bc-972c9fe0791711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72789-045-06727890045066 TABLET in 1 BOTTLE, PLASTIC (72789-045-06) 6 tablet2021-01-040000-00-00NoNoCurrent
72789-045-127278900451212 TABLET in 1 BOTTLE, PLASTIC (72789-045-12) 12 tablet2021-01-060000-00-00NoNoCurrent