Acetazolamide

Product NDC
62135-608
11-digit product format
621350608
Labeler code
62135
Product ID
62135-608_2420d256-1179-5cf2-e063-6394a90ae9a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA205530
Marketing category
ANDA
Marketing start
2016-10-27
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetazolamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAZOLAMIDE250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui197303, 197304

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
62135-608-12Acetazolamide120 in 1 BOTTLETABLET1202

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-608-12EA - Each62135-60851821199-f909-4bcd-98d9-8ad318f01f3112023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-608ACETAZOLAMIDE TABLET [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241012_f75bbf55-98ac-4f91-b6fd-17b5ac860e55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNf75bbf55-98ac-4f91-b6fd-17b5ac860e552
197304acetaZOLAMIDE 250 MG Oral TabletPSNf75bbf55-98ac-4f91-b6fd-17b5ac860e552
197303acetazolamide 125 MG Oral TabletSCDf75bbf55-98ac-4f91-b6fd-17b5ac860e552
197304acetazolamide 250 MG Oral TabletSCDf75bbf55-98ac-4f91-b6fd-17b5ac860e552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-608-1262135060812120 TABLET in 1 BOTTLE (62135-608-12) 120 tablet2023-05-09NoNoHistorical