Acetazolamide

Product NDC
10135-772
11-digit product format
101350772
Labeler code
10135
Product ID
10135-772_efe4aced-f725-4cc0-e053-2a95a90ae650
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Marlex Pharmaceuticals, Inc.
Application
ANDA210588
Marketing category
ANDA
Marketing start
2022-12-01
Marketing end
0000-00-00
Substance
ACETAZOLAMIDE
Active strength
125 mg/1
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-772-01Acetazolamide100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-772-01EA - Each10135-772e3a83986-888f-451c-adbf-04ef2bfa382a12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10135-772ACETAZOLAMIDE TABLET [MARLEX PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20240915_efe4aced-f724-4cc0-e053-2a95a90ae650.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNefe4aced-f724-4cc0-e053-2a95a90ae6503
197304acetaZOLAMIDE 250 MG Oral TabletPSNefe4aced-f724-4cc0-e053-2a95a90ae6503
197303acetazolamide 125 MG Oral TabletSCDefe4aced-f724-4cc0-e053-2a95a90ae6503
197304acetazolamide 250 MG Oral TabletSCDefe4aced-f724-4cc0-e053-2a95a90ae6503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10135-772-0110135077201100 TABLET in 1 BOTTLE (10135-772-01) 100 tablet2022-12-010000-00-00NoNoCurrent