acetaZOLAMIDE

Product NDC
70710-1238
11-digit product format
707101238
Labeler code
70710
Product ID
70710-1238_b8ec300c-c64c-4a65-a101-66644f64f9f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaZOLAMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA211069
Marketing category
ANDA
Marketing start
2023-08-04
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, 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1238-1acetaZOLAMIDE100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1238ACETAZOLAMIDE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]3Current NDC, 1 package rows20240328_85e4d8f6-1e82-4068-a768-752287d4ccf2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN85e4d8f6-1e82-4068-a768-752287d4ccf23
197304acetaZOLAMIDE 250 MG Oral TabletPSN85e4d8f6-1e82-4068-a768-752287d4ccf23
197303acetazolamide 125 MG Oral TabletSCD85e4d8f6-1e82-4068-a768-752287d4ccf23
197304acetazolamide 250 MG Oral TabletSCD85e4d8f6-1e82-4068-a768-752287d4ccf23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70710-1238-170710123801100 TABLET in 1 BOTTLE (70710-1238-1) 100 tablet2023-08-04NoNoCurrent