acetazolamide

Product NDC
42291-089
11-digit product format
422910089
Labeler code
42291
Product ID
42291-089_4b947afe-c73a-556b-e063-6294a90adeef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
AvKARE
Application
ANDA205530
Marketing category
ANDA
Marketing start
2017-05-18
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, 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
42291-089-01acetazolamide100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-089-01EA - Each42291-08982366d8d-4e9f-4ee4-8cc4-627f31ccf71e12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-089ACETAZOLAMIDE TABLET [AVKARE]5Current NDC, Legacy NDC, 1 package rows20240110_d6fba129-ac6e-4d04-bd09-8470be4e7ecc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197304acetaZOLAMIDE 250 MG Oral TabletPSNd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197303acetazolamide 125 MG Oral TabletSCDd6fba129-ac6e-4d04-bd09-8470be4e7ecc7
197304acetazolamide 250 MG Oral TabletSCDd6fba129-ac6e-4d04-bd09-8470be4e7ecc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-089-0142291008901100 TABLET in 1 BOTTLE (42291-089-01) 100 tablet2017-05-180000-00-00NoNoCurrent