FDA.reportPublic FDA data

acetazolamide

Product NDC
70710-1591
11-digit product format
707101591
Labeler code
70710
Product ID
70710-1591_4ee1e84b-1f11-43bb-8945-e6e302c58685
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acetazolamide
Dosage form
CAPSULE
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA205301
Marketing category
ANDA
Marketing start
2019-05-08
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
d0adda24-c2d3-39f8-a845-ede9cd56b2c4Product name620210513
91efc97d-7785-4097-b6cf-4201369f41ebProduct name320190711

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1591-0acetazolamide1000 in 1 BOTTLECAPSULE10008
70710-1591-1acetazolamide100 in 1 BOTTLECAPSULE1008
70710-1591-3acetazolamide30 in 1 BOTTLECAPSULE308
70710-1591-4acetazolamide10 in 1 BLISTER PACKCAPSULE108
70710-1591-4acetazolamide10 in 1 CARTONCAPSULE108
70710-1591-5acetazolamide500 in 1 BOTTLECAPSULE5008
70710-1591-9acetazolamide90 in 1 BOTTLECAPSULE908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1591-1EA - Each70710-159155671302-c3bc-46f9-8d04-26bde539c17012020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1591ACETAZOLAMIDE CAPSULE [ZYDUS PHARMACEUTICALS (USA) INC.]8Current NDC, Legacy NDC, 7 package rows20241012_bf514e99-4958-44a0-a87a-02a950f87e60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNbf514e99-4958-44a0-a87a-02a950f87e608
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDbf514e99-4958-44a0-a87a-02a950f87e608
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYbf514e99-4958-44a0-a87a-02a950f87e608
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSN4e8797d9-2e78-49e0-af25-ac5d1f7924995
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCD4e8797d9-2e78-49e0-af25-ac5d1f7924995
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSY4e8797d9-2e78-49e0-af25-ac5d1f7924995

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1591-0707101591001000 CAPSULE in 1 BOTTLE (70710-1591-0) 1000 capsule2019-05-080000-00-00NoNoCurrent
70710-1591-170710159101100 CAPSULE in 1 BOTTLE (70710-1591-1) 100 capsule2019-05-080000-00-00NoNoCurrent
70710-1591-37071015910330 CAPSULE in 1 BOTTLE (70710-1591-3) 30 capsule2019-05-080000-00-00NoNoCurrent
70710-1591-47071015910410 BLISTER PACK in 1 CARTON (70710-1591-4) / 10 CAPSULE in 1 BLISTER PACK10 blister pack2019-05-080000-00-00NoNoCurrent
70710-1591-570710159105500 CAPSULE in 1 BOTTLE (70710-1591-5) 500 capsule2019-05-080000-00-00NoNoCurrent
70710-1591-97071015910990 CAPSULE in 1 BOTTLE (70710-1591-9) 90 capsule2019-05-080000-00-00NoNoCurrent