Acetazolamide

Product NDC
50090-5945
11-digit product format
500905945
Labeler code
50090
Product ID
50090-5945_acc7ad78-6382-40e2-a9f2-6344f04648cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040904
Marketing category
ANDA
Marketing start
2021-02-15
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
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
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
50090-5945-0Acetazolamide30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5945-0EA - Each50090-5945646bfa6a-024c-489c-aa09-f6af88cc622212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5945ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 1 package rows20231115_c5acf531-ba55-47b7-88db-e5da0206ebf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNc5acf531-ba55-47b7-88db-e5da0206ebf15
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDc5acf531-ba55-47b7-88db-e5da0206ebf15
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYc5acf531-ba55-47b7-88db-e5da0206ebf15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-5945-05009059450030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-5945-0) 2022-03-230000-00-00NoNoCurrent