Acetazolamide

Product NDC
70518-4646
11-digit product format
705184646
Labeler code
70518
Product ID
70518-4646_508b15b8-2f21-c075-e063-6394a90af64d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA040904
Marketing category
ANDA
Marketing start
2026-04-28
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
70518-4646-0Acetazolamide50 in 1 BOXCAPSULE, EXTENDED RELEASE501
70518-4646-1Acetazolamide1 in 1 POUCHCAPSULE, EXTENDED RELEASE11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-4646-07051846460050 POUCH in 1 BOX (70518-4646-0) / 1 CAPSULE, EXTENDED RELEASE in 1 POUCH (70518-4646-1) 50 pouch2026-04-28NoNoCurrent
70518-4646-1705184646011 in 1 POUCHHistorical