Acetazolamide

Product NDC
23155-831
11-digit product format
231550831
Labeler code
23155
Product ID
23155-831_c4181e7e-fe5c-47ea-b442-a115eee18238
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA202693
Marketing category
ANDA
Marketing start
2022-11-15
Marketing end
2027-09-30
Substance
ACETAZOLAMIDE SODIUM
Active strength
500 mg/5mL
Pharmacologic classes
Carbonic Anhydrase Inhibitor [EPC], Carbonic Anhydrase Inhibitors [MoA], Sulfonamides [CS]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetazolamide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAZOLAMIDE SODIUM500 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii429ZT169UH
Rxcui307702

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
23155-831-31Acetazolamide1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19
23155-831-31Acetazolamide5 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-831-31EA - Each23155-8315ad4f775-a44a-43ef-9efa-d2d6c60dad2812023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-831ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20250516_4dd56001-4941-4ff0-9f30-02a1bcc4fe7e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307702acetaZOLAMIDE 500 MG InjectionPSN4dd56001-4941-4ff0-9f30-02a1bcc4fe7e9
307702acetazolamide 500 MG InjectionSCD4dd56001-4941-4ff0-9f30-02a1bcc4fe7e9
307702acetazolamide (as acetazolamide sodium) 500 MG InjectionSY4dd56001-4941-4ff0-9f30-02a1bcc4fe7e9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-831-31231550831311 VIAL, GLASS in 1 CARTON (23155-831-31) / 5 mL in 1 VIAL, GLASS2022-11-152027-09-30NoNoCurrent