FDA.reportPublic FDA data

Acetazolamide

Product NDC
50090-3132
11-digit product format
500903132
Labeler code
50090
Product ID
50090-3132_4db9b259-b15f-4d79-b892-483d4f182297
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090779
Marketing category
ANDA
Marketing start
2012-09-24
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3132-02023-01-30C16284748780-1f386c64a-49f5-0266-e053-dadaa90a7c1aAcetazolamide Extended-Release Capsules These highlights do not include all the information needed to use Acetazolamide safely and effectively. See full prescribing information for Acetazolamide Acetazolamide (Acetazolamide) CAPSULE, EXTENDED RELEASE for ORAL use. Initial U.S. Approval:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3132-0Acetazolamide30 in 1 BOTTLECAPSULE, EXTENDED RELEASE305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3132-0EA - Each50090-31322981d8ff-f2a1-4bf1-b8df-0794a76c455b12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3132ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20210417_98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c95
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c95
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY98ee6c4e-cfe4-4fd0-b04f-2a5fd9c490c95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3132-05009031320030 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (50090-3132-0) 2017-09-060000-00-00NoNoCurrent