FDA.reportPublic FDA data

acetazolamide

Product NDC
71335-9729
11-digit product format
713359729
Labeler code
71335
Product ID
71335-9729_5b36deea-8e75-4379-a797-048641a8bf19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA207659
Marketing category
ANDA
Marketing start
2021-11-19
Substance
ACETAZOLAMIDE
Active strength
500 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
ACETAZOLAMIDE500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO3FX965V0I
Rxcui562524

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-9729-1acetazolamide180 in 1 BOTTLECAPSULE, EXTENDED RELEASE180103
71335-9729-2acetazolamide100 in 1 BOTTLECAPSULE, EXTENDED RELEASE100103
71335-9729-3acetazolamide30 in 1 BOTTLECAPSULE, EXTENDED RELEASE30103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9729ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]102Current NDC, 3 package rows20250403_0d903375-c583-4362-9f8a-f7b74ce01e0b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN0d903375-c583-4362-9f8a-f7b74ce01e0b103
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD0d903375-c583-4362-9f8a-f7b74ce01e0b103
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY0d903375-c583-4362-9f8a-f7b74ce01e0b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9729-171335972901180 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9729-1) 2026-04-09NoNoHistorical
71335-9729-271335972902100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9729-2) 2023-06-09NoNoHistorical
71335-9729-37133597290330 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (71335-9729-3) 2026-04-09NoNoHistorical