AcetaZOLAMIDE

Product NDC
10135-567
11-digit product format
101350567
Labeler code
10135
Product ID
10135-567_3bfbaa55-8b5c-4a57-ad02-c5a9c943e3e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals Inc
Application
ANDA084840
Marketing category
ANDA
Marketing start
2014-10-01
Marketing end
0000-00-00
Substance
ACETAZOLAMIDE
Active strength
250 mg/1
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC],Carbonic Anhydrase Inhibitors [MoA],Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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
10135-567-012021-01-29C16284748780-1ba0f9c33-15ed-a910-e053-dadaa90a0b85AcetaZOLAMIDE TABLETS USP
10135-567-052021-01-29C16284748780-1ba0f9c33-15ed-a910-e053-dadaa90a0b85AcetaZOLAMIDE TABLETS USP
10135-567-102021-01-29C16284748780-1ba0f9c33-15ed-a910-e053-dadaa90a0b85AcetaZOLAMIDE TABLETS USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-567-01AcetaZOLAMIDE100 in 1 BOTTLETABLET1002
10135-567-05AcetaZOLAMIDE500 in 1 BOTTLETABLET5002
10135-567-10AcetaZOLAMIDE1000 in 1 BOTTLETABLET10002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-567-01EA - Each10135-567248ac5f6-da95-413e-bb0b-ed35e183359012015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAZOLAMIDEACTIVE INGREDIENTO3FX965V0IACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]1
ACETAZOLAMIDEACTIVE MOIETYO3FX965V0IACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-567ACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS INC]2Legacy NDC, 3 package rows20191112_8cd20635-91d0-4565-bc2c-778806178ac8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197304acetaZOLAMIDE 250 MG Oral TabletPSN8cd20635-91d0-4565-bc2c-778806178ac82
197304acetazolamide 250 MG Oral TabletSCD8cd20635-91d0-4565-bc2c-778806178ac82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10135-567-0110135056701100 in 1 BOTTLEHistorical
10135-567-0510135056705500 in 1 BOTTLEHistorical
10135-567-10101350567101000 in 1 BOTTLEHistorical