AcetaZOLAMIDE

Product NDC
0143-9503
11-digit product format
001439503
Labeler code
0143
Product ID
0143-9503_c73d8fc8-46a9-40ab-925b-8f76980a2f1f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
ANDA040089
Marketing category
ANDA
Marketing start
1996-05-01
Substance
ACETAZOLAMIDE SODIUM
Active strength
500 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
ACETAZOLAMIDE SODIUM500 mg/1

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
0143-9503-01AcetaZOLAMIDE1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,18
0143-9503-01AcetaZOLAMIDE1 in 1 BOX, UNIT-DOSEINJECTION, POWDER, LYOPHILIZED,18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9503-01EA - Each0143-9503b13dac4e-a829-4a2e-ae71-b4a363e84f9512017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9503ACETAZOLAMIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20250206_85975cf0-1286-4af9-ac7f-94bb2483bf09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307702acetaZOLAMIDE 500 MG InjectionPSN85975cf0-1286-4af9-ac7f-94bb2483bf098
307702acetazolamide 500 MG InjectionSCD85975cf0-1286-4af9-ac7f-94bb2483bf098
307702acetazolamide (as acetazolamide sodium) 500 MG InjectionSY85975cf0-1286-4af9-ac7f-94bb2483bf098

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0143-9503-01001439503011 VIAL in 1 BOX, UNIT-DOSE (0143-9503-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL1 vial1996-05-010000-00-00NoNoCurrent