Acetazolamide

Product NDC
63629-1194
11-digit product format
636291194
Labeler code
63629
Product ID
63629-1194_e31047fd-d413-4eaf-a956-9e58acc0e534
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA214282
Marketing category
ANDA
Marketing start
2020-11-13
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
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
ACETAZOLAMIDE125 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui197303

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
63629-1194-1Acetazolamide100 in 1 BOTTLETABLET100107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1194-1EA - Each63629-11943c13248f-2fb6-4756-8a84-d68ebf7d9c2a12021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1194ACETAZOLAMIDE TABLET [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20241108_f7227cc5-0a80-47df-baf8-09f1b22b187e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNf7227cc5-0a80-47df-baf8-09f1b22b187e107
197303acetazolamide 125 MG Oral TabletSCDf7227cc5-0a80-47df-baf8-09f1b22b187e107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1194-163629119401100 TABLET in 1 BOTTLE (63629-1194-1) 100 tablet2024-10-290000-00-00NoNoCurrent