FDA.reportPublic FDA data

Acetazolamide

Product NDC
71205-308
11-digit product format
712050308
Labeler code
71205
Product ID
71205-308_ad9d406c-3d6e-4576-99b0-402fcefedc81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA209734
Marketing category
ANDA
Marketing start
2017-11-21
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
71205-308-30Acetazolamide30 in 1 BOTTLETABLET302
71205-308-60Acetazolamide60 in 1 BOTTLETABLET602
71205-308-90Acetazolamide90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-308-30EA - Each71205-308ccfd67fb-80a5-4f65-92a9-97d8b808106912019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-308ACETAZOLAMIDE TABLET [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20191005_3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc2
197303acetazolamide 125 MG Oral TabletSCD3cdde6aa-c89d-4ea4-aade-6c8b5c3ffdcc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-308-307120503083030 TABLET in 1 BOTTLE (71205-308-30) 30 tablet2019-09-010000-00-00NoNoCurrent
71205-308-607120503086060 TABLET in 1 BOTTLE (71205-308-60) 60 tablet2019-09-010000-00-00NoNoCurrent
71205-308-907120503089090 TABLET in 1 BOTTLE (71205-308-90) 90 tablet2019-09-010000-00-00NoNoCurrent