Acetazolamide

Product NDC
69367-209
11-digit product format
693670209
Labeler code
69367
Product ID
69367-209_c04410c8-e55f-4f15-a10d-9d94476bde16
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Application
ANDA090779
Marketing category
ANDA
Marketing start
2023-04-20
Marketing end
2028-05-01
Substance
ACETAZOLAMIDE
Active strength
500 mg/1
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetazolamide

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
69367-209-01Acetazolamide100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-209-01EA - Each69367-2095f6a3e04-f98f-4ee9-90b4-14c98d63d1f812023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69367-209ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [WESTMINSTER PHARMACEUTICALS, LLC]2Current NDC, 1 package rows20250328_417b1df2-63bc-473c-9e02-5f93dd45554d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN417b1df2-63bc-473c-9e02-5f93dd45554d3
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD417b1df2-63bc-473c-9e02-5f93dd45554d3
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY417b1df2-63bc-473c-9e02-5f93dd45554d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69367-209-0169367020901100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69367-209-01) 2023-04-202028-05-01NoNoHistorical