FDA.reportPublic FDA data

Acetazolamide

Product NDC
55289-720
11-digit product format
552890720
Labeler code
55289
Product ID
55289-720_3467aca9-10ce-20d3-e063-6394a90a6743
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA040195
Marketing category
ANDA
Marketing start
1997-05-28
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
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
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
55289-720-06Acetazolamide6 in 1 BOTTLE, PLASTICTABLET617
55289-720-12Acetazolamide12 in 1 BOTTLE, PLASTICTABLET1217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-720-06EA - Each55289-72088ae8f98-f3a1-4c72-885a-a2a6e730b0b212016-04-04
55289-720-12EA - Each55289-7209eecc607-0146-4a51-a3b8-98e5e49177c412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AcetazolamideACTIVE INGREDIENTO3FX965V0IACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
AcetazolamideACTIVE MOIETYO3FX965V0IACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
GelatinINACTIVE INGREDIENT2G86QN327LACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
GlycerinINACTIVE INGREDIENTPDC6A3C0OXACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
Lactose MonohydrateINACTIVE INGREDIENTEWQ57Q8I5XACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
Magnesium StearateINACTIVE INGREDIENT70097M6I30ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
Sodium Starch Glycolate Type A PotatoINACTIVE INGREDIENT5856J3G2A2ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
Starch, CornINACTIVE INGREDIENTO8232NY3SJACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
TalcINACTIVE INGREDIENT7SEV7J4R1UACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-720ACETAZOLAMIDE TABLET [PD-RX PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 2 package rows20250507_bd911de5-ea56-41ba-a328-20c8bfe7fe3b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNbd911de5-ea56-41ba-a328-20c8bfe7fe3b17
197303acetazolamide 125 MG Oral TabletSCDbd911de5-ea56-41ba-a328-20c8bfe7fe3b17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-720-06552890720066 TABLET in 1 BOTTLE, PLASTIC (55289-720-06) 6 tablet2016-03-030000-00-00NoNoCurrent
55289-720-125528907201212 TABLET in 1 BOTTLE, PLASTIC (55289-720-12) 12 tablet2016-03-030000-00-00NoNoCurrent