Methsuximide

Product NDC
70954-228
11-digit product format
709540228
Labeler code
70954
Product ID
70954-228_5138e347-665b-4dd6-b9f8-12f4a807ed4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methsuximide
Dosage form
CAPSULE
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA217213
Marketing category
ANDA
Marketing start
2023-05-01
Substance
METHSUXIMIDE
Active strength
300 mg/1
Pharmacologic classes
Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHSUXIMIDE300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0G76K8X6C0
Rxcui197949

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c66d0cbc-4684-658d-2453-91fa387ed8caProduct name220240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70954-228-10Methsuximide100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-228-10EA - Each70954-228c16e4b37-6cf7-4cb1-8b6d-c3fe8097c4c412023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-228METHSUXIMIDE CAPSULE [ANI PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20230504_5138e347-665b-4dd6-b9f8-12f4a807ed4e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197949methsuximide 300 MG Oral CapsulePSN5138e347-665b-4dd6-b9f8-12f4a807ed4e1
197949methsuximide 300 MG Oral CapsuleSCD5138e347-665b-4dd6-b9f8-12f4a807ed4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70954-228-1070954022810100 CAPSULE in 1 BOTTLE (70954-228-10) 100 capsule2023-05-01NoNoHistorical