FDA.reportPublic FDA data

acetazolamide

Product NDC
16729-331
11-digit product format
167290331
Labeler code
16729
Product ID
16729-331_45ffaa19-26c0-d41f-e063-6394a90ad7c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Accord Healthcare Inc.
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
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
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
16729-331-01acetazolamide100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1008
16729-331-17acetazolamide1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-331-01EA - Each16729-331d55503bb-01fa-4ea4-8761-1461d9ef7c5f12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-331ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ACCORD HEALTHCARE INC.]7Current NDC, Legacy NDC, 2 package rows20250213_9a368b35-cd51-47ad-83cc-ccc56c4585e8.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
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN9a368b35-cd51-47ad-83cc-ccc56c4585e88
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD9a368b35-cd51-47ad-83cc-ccc56c4585e88
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY9a368b35-cd51-47ad-83cc-ccc56c4585e88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-331-0116729033101100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (16729-331-01) 2021-11-190000-00-00NoNoCurrent
16729-331-17167290331171000 in 1 BOTTLEHistorical