FDA.reportPublic FDA data

ACETAZOLAMIDE EXTENDED-RELEASE

Product NDC
50268-042
11-digit product format
502680042
Labeler code
50268
Product ID
50268-042_0e84c7df-dbb4-d445-e063-6394a90ab528
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide Extended-Release
Dosage form
CAPSULE
Route
ORAL
Labeler
AvPAK
Application
ANDA207401
Marketing category
ANDA
Marketing start
2022-07-20
Substance
ACETAZOLAMIDE
Active strength
500 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 EXTENDED-RELEASE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAZOLAMIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui562524

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
50268-042-11ACETAZOLAMIDE EXTENDED-RELEASE1 in 1 BLISTER PACKCAPSULE12
50268-042-12ACETAZOLAMIDE EXTENDED-RELEASE20 in 1 BOXCAPSULE202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-042-11EA - Each50268-04219084758-9229-41d2-8c30-57a4e3ad339012022-09-12
50268-042-12EA - Each50268-042725e64fc-0d71-4ce7-88ac-b106fe8f220512022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-042ACETAZOLAMIDE EXTENDED-RELEASE CAPSULE [AVPAK]2Current NDC, Legacy NDC, 2 package rows20240129_e43f991d-15b9-1e66-e053-2a95a90a9449.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNe43f991d-15b9-1e66-e053-2a95a90a94492
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDe43f991d-15b9-1e66-e053-2a95a90a94492
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYe43f991d-15b9-1e66-e053-2a95a90a94492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-042-11502680042111 in 1 BLISTER PACKHistorical
50268-042-125026800421220 BLISTER PACK in 1 BOX (50268-042-12) / 1 CAPSULE in 1 BLISTER PACK (50268-042-11) 20 blister pack2022-07-200000-00-00NoNoCurrent