Acetazolamide

Product NDC
62332-349
11-digit product format
623320349
Labeler code
62332
Product ID
62332-349_5e12d289-e62f-4b85-a419-ec24a39049ba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA210423
Marketing category
ANDA
Marketing start
2019-02-20
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
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-349-31Acetazolamide100 in 1 BOTTLECAPSULE, EXTENDED RELEASE1006
62332-349-91Acetazolamide1000 in 1 BOTTLECAPSULE, EXTENDED RELEASE10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-349-31EA - Each62332-34926c4d660-5e91-4a63-ac26-fe837597a66212019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-349ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 2 package rows20241031_43231abb-2a5d-44ab-b3e6-7564a1131ac5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN43231abb-2a5d-44ab-b3e6-7564a1131ac56
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD43231abb-2a5d-44ab-b3e6-7564a1131ac56
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY43231abb-2a5d-44ab-b3e6-7564a1131ac56

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-349-3162332034931100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-349-31) 2019-02-200000-00-00NoNoCurrent
62332-349-91623320349911000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62332-349-91) 2019-02-200000-00-00NoNoCurrent