acetazolamide

Product NDC
65841-762
11-digit product format
658410762
Labeler code
65841
Product ID
65841-762_bb74273d-215a-4983-bfa1-7d649f6872d5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA205301
Marketing category
ANDA
Marketing start
2019-04-10
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
65841-762-01acetazolamide100 in 1 BOTTLECAPSULE1006
65841-762-05acetazolamide500 in 1 BOTTLECAPSULE5006
65841-762-06acetazolamide30 in 1 BOTTLECAPSULE306
65841-762-10acetazolamide1000 in 1 BOTTLECAPSULE10006
65841-762-16acetazolamide90 in 1 BOTTLECAPSULE906
65841-762-30acetazolamide10 in 1 BLISTER PACKCAPSULE106
65841-762-30acetazolamide10 in 1 CARTONCAPSULE106

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-762ACETAZOLAMIDE CAPSULE [ZYDUS LIFESCIENCES LIMITED]6Current NDC, Legacy NDC, 7 package rows20241012_2c1d9078-c15f-4dce-bc26-edfa5400fa9b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN2c1d9078-c15f-4dce-bc26-edfa5400fa9b6
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD2c1d9078-c15f-4dce-bc26-edfa5400fa9b6
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY2c1d9078-c15f-4dce-bc26-edfa5400fa9b6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-762-0165841076201100 CAPSULE in 1 BOTTLE (65841-762-01) 100 capsule2019-04-100000-00-00NoNoCurrent
65841-762-0565841076205500 CAPSULE in 1 BOTTLE (65841-762-05) 500 capsule2019-04-100000-00-00NoNoCurrent
65841-762-066584107620630 CAPSULE in 1 BOTTLE (65841-762-06) 30 capsule2019-04-100000-00-00NoNoCurrent
65841-762-10658410762101000 CAPSULE in 1 BOTTLE (65841-762-10) 1000 capsule2019-04-100000-00-00NoNoCurrent
65841-762-166584107621690 CAPSULE in 1 BOTTLE (65841-762-16) 90 capsule2019-04-100000-00-00NoNoCurrent
65841-762-306584107623010 BLISTER PACK in 1 CARTON (65841-762-30) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-04-100000-00-00NoNoCurrent