ACETAZOLAMIDE EXTENDED-RELEASE

Product NDC
42571-243
11-digit product format
425710243
Labeler code
42571
Product ID
42571-243_456f5ce4-6ad1-f0a1-e063-6294a90a0fac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide extended-release
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA207401
Marketing category
ANDA
Marketing start
2020-12-01
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
42571-243-01ACETAZOLAMIDE EXTENDED-RELEASE100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-243-01EA - Each42571-243223f7fcd-09ea-41da-9aa0-f1c54bc62d3912021-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-243ACETAZOLAMIDE EXTENDED-RELEASE (ACETAZOLAMIDE EXTENDED-RELEASE) CAPSULE [MICRO LABS LIMITED]6Current NDC, Legacy NDC, 1 package rows20250112_78f78919-a6ba-4072-bc45-2ab3637ed894.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN78f78919-a6ba-4072-bc45-2ab3637ed8947
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD78f78919-a6ba-4072-bc45-2ab3637ed8947
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY78f78919-a6ba-4072-bc45-2ab3637ed8947
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
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN8e396b27-b44a-4aa9-805b-086395444b5f1
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD8e396b27-b44a-4aa9-805b-086395444b5f1
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY8e396b27-b44a-4aa9-805b-086395444b5f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-243-0142571024301100 CAPSULE in 1 BOTTLE (42571-243-01) 100 capsule2020-12-010000-00-00NoNoCurrent