Acetazolamide

Product NDC
23155-787
11-digit product format
231550787
Labeler code
23155
Product ID
23155-787_073d722e-b1d4-4b55-a059-c4eb41278f4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA040904
Marketing category
ANDA
Marketing start
2021-02-15
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
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
23155-787-01Acetazolamide100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-787-01EA - Each23155-787ecfa6441-336d-4a4b-be9b-8c765302319b12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-787ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]4Current NDC, Legacy NDC, 1 package rows20241212_33d912ea-9e1c-49eb-bd93-f0b1b2da67b6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN33d912ea-9e1c-49eb-bd93-f0b1b2da67b65
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNc5acf531-ba55-47b7-88db-e5da0206ebf15
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD33d912ea-9e1c-49eb-bd93-f0b1b2da67b65
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDc5acf531-ba55-47b7-88db-e5da0206ebf15
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY33d912ea-9e1c-49eb-bd93-f0b1b2da67b65
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYc5acf531-ba55-47b7-88db-e5da0206ebf15
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNfb2cf8fe-da81-445e-a18b-9aa9ced1d34a1
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDfb2cf8fe-da81-445e-a18b-9aa9ced1d34a1
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYfb2cf8fe-da81-445e-a18b-9aa9ced1d34a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
23155-787-0123155078701100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (23155-787-01) 2021-02-150000-00-00NoNoCurrent