Acetazolamide

Product NDC
70954-033
11-digit product format
709540033
Labeler code
70954
Product ID
70954-033_bf074cfc-87f3-4328-a251-65f3f9d8556e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA210588
Marketing category
ANDA
Marketing start
2019-10-17
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
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
ACETAZOLAMIDE125 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
70954-033-20Acetazolamide1000 in 1 BOTTLETABLET10007
70954-033-30Acetazolamide100 in 1 BOTTLETABLET1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-033-30EA - Each70954-033722b1517-0f99-468a-8468-f5234dc10a9112020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-033ACETAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20250214_bde94a48-05d0-45a0-a589-ec05b7d16532.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSNbde94a48-05d0-45a0-a589-ec05b7d165327
197304acetaZOLAMIDE 250 MG Oral TabletPSNbde94a48-05d0-45a0-a589-ec05b7d165327
197303acetazolamide 125 MG Oral TabletSCDbde94a48-05d0-45a0-a589-ec05b7d165327
197304acetazolamide 250 MG Oral TabletSCDbde94a48-05d0-45a0-a589-ec05b7d165327

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-033-20709540033201000 TABLET in 1 BOTTLE (70954-033-20) 1000 tablet2019-10-170000-00-00NoNoCurrent
70954-033-3070954003330100 TABLET in 1 BOTTLE (70954-033-30) 100 tablet2019-10-170000-00-00NoNoCurrent