Acetazolamide

Product NDC
62135-612
11-digit product format
621350612
Labeler code
62135
Product ID
62135-612_2420ae6d-8967-ef58-e063-6394a90a9656
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acetazolamide
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Chartwell RX, LLC
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
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
62135-612-60Acetazolamide60 in 1 PACKAGECAPSULE, EXTENDED RELEASE602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62135-612-60EA - Each62135-6127889968b-3a29-491a-9ad8-f21bd172786112023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-612ACETAZOLAMIDE CAPSULE, EXTENDED RELEASE [CHARTWELL RX, LLC]2Current NDC, 1 package rows20241012_e8e48a25-5f6c-4b5a-a5f2-ee87aabea33b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562524acetaZOLAMIDE 500 MG 12HR Extended Release Oral CapsulePSNe8e48a25-5f6c-4b5a-a5f2-ee87aabea33b2
56252412 HR acetazolamide 500 MG Extended Release Oral CapsuleSCDe8e48a25-5f6c-4b5a-a5f2-ee87aabea33b2
562524acetazolamide 500 MG 12 HR Extended Release Oral CapsuleSYe8e48a25-5f6c-4b5a-a5f2-ee87aabea33b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62135-612-606213506126060 CAPSULE, EXTENDED RELEASE in 1 PACKAGE (62135-612-60) 2023-05-09NoNoHistorical