Acetazolamide

Product NDC
50742-233
11-digit product format
507420233
Labeler code
50742
Product ID
50742-233_7b0e4b3b-5f80-43bb-8a22-686d8323d86e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Ingenus Pharmaceuticals, LLC
Application
ANDA203434
Marketing category
ANDA
Marketing start
2017-07-31
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
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
50742-233-01Acetazolamide100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50742-233-01EA - Each50742-233983a1a01-a20b-4277-9ea3-a43b62383b3612017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50742-233ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [INGENUS PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 1 package rows20221217_a1f6ed35-9188-4115-8a3c-1ac91c07bf7d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNa1f6ed35-9188-4115-8a3c-1ac91c07bf7d5
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDa1f6ed35-9188-4115-8a3c-1ac91c07bf7d5
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYa1f6ed35-9188-4115-8a3c-1ac91c07bf7d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50742-233-0150742023301100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50742-233-01) 2017-07-310000-00-00NoNoCurrent