Acetazolamide

Product NDC
68071-3550
11-digit product format
680713550
Labeler code
68071
Product ID
68071-3550_2d3fc60b-5a3e-6abc-e063-6394a90af2a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA215101
Marketing category
ANDA
Marketing start
2021-08-19
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-3550-12025-02-03C16284748780-12cef2736-abf8-d83d-e063-dadaa90ab31fAcetaZOLAMIDE Tablets USP
68071-3550-12025-01-30C16284748780-12cef2736-abf8-d83d-e063-dadaa90ab31fAcetaZOLAMIDE Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3550-1Acetazolamide12 in 1 BOTTLETABLET122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3550ACETAZOLAMIDE TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250205_0b76c194-b244-e9ac-e063-6394a90a373e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197303acetaZOLAMIDE 125 MG Oral TabletPSN0b76c194-b244-e9ac-e063-6394a90a373e2
197303acetazolamide 125 MG Oral TabletSCD0b76c194-b244-e9ac-e063-6394a90a373e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3550-16807135500112 TABLET in 1 BOTTLE (68071-3550-1) 12 tablet2023-12-01NoNoCurrent