Acetazolamide

Product NDC
25021-839
11-digit product format
250210839
Labeler code
25021
Product ID
25021-839_2b64b799-67b1-41b7-ad0d-7c160c6efd58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Sagent Pharmaceuticals
Application
ANDA219775
Marketing category
ANDA
Marketing start
2026-01-15
Substance
ACETAZOLAMIDE SODIUM
Active strength
500 mg/5mL
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
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
25021-839-20Acetazolamide5 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION51
25021-839-20Acetazolamide1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
25021-839-20EA - Each25021-839725bb3a8-9ef6-4f07-a018-c87587e90da312026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307702acetaZOLAMIDE 500 MG InjectionPSN58093032-8480-4d0f-82be-92e643bdbea41
307702acetazolamide 500 MG InjectionSCD58093032-8480-4d0f-82be-92e643bdbea41
307702acetazolamide (as acetazolamide sodium) 500 MG InjectionSY58093032-8480-4d0f-82be-92e643bdbea41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
25021-839-20250210839201 VIAL in 1 CARTON (25021-839-20) / 5 mL in 1 VIAL1 vial2026-01-15NoNoHistorical