ACETAZOLAMIDE EXTENDED-RELEASE

Product NDC
50090-5608
11-digit product format
500905608
Labeler code
50090
Product ID
50090-5608_70d9b232-aa2e-4654-ada8-11b29f4562c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide Extended-Release
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207401
Marketing category
ANDA
Marketing start
2020-12-01
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
50090-5608-02023-01-30C16284748780-1f386c649-bffc-0266-e053-dadaa90a7c1aAcetazolamide Extended-Release Capsules Issued JUNE 2014 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5608-0ACETAZOLAMIDE EXTENDED-RELEASE30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5608-0EA - Each50090-5608f4f53911-e652-4458-8a95-b64a1eb046ca12022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5608ACETAZOLAMIDE EXTENDED-RELEASE (ACETAZOLAMIDE EXTENDED-RELEASE) CAPSULE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20210905_8e396b27-b44a-4aa9-805b-086395444b5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
50090-5608-05009056080030 CAPSULE in 1 BOTTLE (50090-5608-0) 30 capsule2021-08-040000-00-00NoNoCurrent