acetaZOLAMIDE

Product NDC
70771-1827
11-digit product format
707711827
Labeler code
70771
Product ID
70771-1827_859b8e26-b64c-4d17-adbf-0251745c0510
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetaZOLAMIDE
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA211069
Marketing category
ANDA
Marketing start
2023-07-15
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
70771-1827-1acetaZOLAMIDE100 in 1 BOTTLETABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1827ACETAZOLAMIDE TABLET [ZYDUS LIFESCIENCES LIMITED]2Current NDC, 1 package rows20230715_df84fea3-8947-403f-b470-1eeb6c4c293d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNdf84fea3-8947-403f-b470-1eeb6c4c293d3
197304acetaZOLAMIDE 250 MG Oral TabletPSNdf84fea3-8947-403f-b470-1eeb6c4c293d3
197303acetazolamide 125 MG Oral TabletSCDdf84fea3-8947-403f-b470-1eeb6c4c293d3
197304acetazolamide 250 MG Oral TabletSCDdf84fea3-8947-403f-b470-1eeb6c4c293d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1827-170771182701100 TABLET in 1 BOTTLE (70771-1827-1) 100 tablet2023-07-15NoNoCurrent