FDA.reportPublic FDA data

Acetazolamide

Product NDC
50268-054
11-digit product format
502680054
Labeler code
50268
Product ID
50268-054_47e22404-7bca-908d-e063-6294a90a70c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA209734
Marketing category
ANDA
Marketing start
2020-07-07
Substance
ACETAZOLAMIDE
Active strength
250 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
ACETAZOLAMIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui197304

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
50268-054-11Acetazolamide1 in 1 BLISTER PACKTABLET14
50268-054-15Acetazolamide50 in 1 BOXTABLET504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-054-11EA - Each50268-054bf8f41a5-c89f-4e22-ac85-b98962c1a18d12020-08-06
50268-054-15EA - Each50268-05462353d97-515b-4af7-a52e-23a32047f62d12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-054ACETAZOLAMIDE TABLET [AVPAK]3Current NDC, Legacy NDC, 2 package rows20240110_a9dca448-5511-413e-e053-2a95a90a8c66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197304acetaZOLAMIDE 250 MG Oral TabletPSNa9dca448-5511-413e-e053-2a95a90a8c664
197304acetazolamide 250 MG Oral TabletSCDa9dca448-5511-413e-e053-2a95a90a8c664

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-054-11502680054111 in 1 BLISTER PACKHistorical
50268-054-155026800541550 BLISTER PACK in 1 BOX (50268-054-15) / 1 TABLET in 1 BLISTER PACK (50268-054-11) 50 blister pack2020-07-070000-00-00NoNoCurrent