FDA.reportPublic FDA data

Methazolamide

Product NDC
62559-240
11-digit product format
625590240
Labeler code
62559
Product ID
62559-240_7a4099f0-7e1b-49ae-ae13-1463c08daaa5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methazolamide
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA040001
Marketing category
ANDA
Marketing start
2014-11-06
Substance
METHAZOLAMIDE
Active strength
25 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methazolamide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHAZOLAMIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiW733B0S9SD
Rxcui197939, 197940

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a1f610d4-6674-3a87-200e-f2590485d943Product name320231221

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62559-240-01Methazolamide100 in 1 BOTTLETABLET1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-240-01EA - Each62559-2409d93371a-4907-4505-915a-e3e832473a8512014-12-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHAZOLAMIDEACTIVE INGREDIENTW733B0S9SDMETHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1
METHAZOLAMIDEACTIVE MOIETYW733B0S9SDMETHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPMETHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1
GLYCERYL DIBEHENATEINACTIVE INGREDIENTR8WTH25YS2METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EMETHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62559-240METHAZOLAMIDE TABLET [ANI PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 1 package rows20231216_c26c8834-961e-4c9c-9ad4-5db2d9419938.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197939methazolAMIDE 25 MG Oral TabletPSNff710572-ed62-490a-95f1-2b2c2eed08ee104
197939methazolamide 25 MG Oral TabletSCDff710572-ed62-490a-95f1-2b2c2eed08ee104
197939methazolAMIDE 25 MG Oral TabletPSN504b695a-ac9e-4c71-8755-d31f1958a71c101
197939methazolamide 25 MG Oral TabletSCD504b695a-ac9e-4c71-8755-d31f1958a71c101
197939methazolAMIDE 25 MG Oral TabletPSN723f830c-a534-55d1-e053-2a91aa0a403c6
197940methazolAMIDE 50 MG Oral TabletPSN723f830c-a534-55d1-e053-2a91aa0a403c6
197939methazolamide 25 MG Oral TabletSCD723f830c-a534-55d1-e053-2a91aa0a403c6
197940methazolamide 50 MG Oral TabletSCD723f830c-a534-55d1-e053-2a91aa0a403c6
197939methazolAMIDE 25 MG Oral TabletPSNc26c8834-961e-4c9c-9ad4-5db2d94199385
197940methazolAMIDE 50 MG Oral TabletPSNc26c8834-961e-4c9c-9ad4-5db2d94199385
197939methazolamide 25 MG Oral TabletSCDc26c8834-961e-4c9c-9ad4-5db2d94199385
197940methazolamide 50 MG Oral TabletSCDc26c8834-961e-4c9c-9ad4-5db2d94199385

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-240-0162559024001100 TABLET in 1 BOTTLE (62559-240-01) 100 tablet2014-11-060000-00-00NoNoCurrent