FDA.reportPublic FDA data

Ethosuximide

Product NDC
59762-2350
Requested package NDC
59762-2350-7
11-digit product format
597622350
Labeler code
59762
Product ID
59762-2350_51ec0774-2e64-4b64-8da7-7672e6e77736
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ethosuximide
Dosage form
SOLUTION
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA080258
Marketing category
ANDA
Marketing start
2020-02-21
Substance
ETHOSUXIMIDE
Active strength
250 mg/5mL
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A080258-001ZARONTINETHOSUXIMIDE250MG/5MLSYRUP / ORALAARLD, RS, Approved before 1982

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A080258-001AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A080258-001ZARONTIN250MG/5MLSYRUP / ORALAARLD, RS, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A080258-001AA1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EthosuximideETHOSUXIMIDEMylan Pharmaceuticals Inc.19c924c2-f558-4c78-9277-2d7e0df2f5052026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080258
application number: ANDA080258
ndc (package): 59762-2350-7
ndc (product): 59762-2350
ndc11 (package): 59762235007
ZarontinETHOSUXIMIDEParke-Davis Div of Pfizer Inc7bf3e616-45e8-4469-a75d-4d824ce951ea2023-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 080258
application number: ANDA080258

Additional Listing Data#

Finished product
Yes
Brand name base
Ethosuximide
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETHOSUXIMIDE250 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5SEH9X1D1DInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
251322Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
19c924c2-f558-4c78-9277-2d7e0df2f505Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dcc989c7-4ccb-d599-44b3-233abc5285bbProduct name320200708
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-2350-6Ethosuximide474 mL in 1 BOTTLE, PLASTICSOLUTION47416
59762-2350-6Ethosuximide1 in 1 CARTONSOLUTION116
59762-2350-7Ethosuximide474 mL in 1 BOTTLE, PLASTICSOLUTION47416
59762-2350-7Ethosuximide1 in 1 CARTONSOLUTION116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2350-5ML - Milliliter59762-23506c4176c0-7c28-4427-8c3e-ae82aa8bad4412015-11-12
59762-2350-6ML - Milliliter59762-23505ec56ff3-d30f-434f-8caf-3b458536e60512020-03-10
59762-2350-7ML - Milliliter59762-2350abce0368-9113-452e-9871-faed529661a212022-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHOSUXIMIDEACTIVE INGREDIENT5SEH9X1D1DETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
ETHOSUXIMIDEACTIVE MOIETY5SEH9X1D1DETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
SUCROSEINACTIVE INGREDIENTC151H8M554ETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RETHOSUXIMIDE SOLUTION [GREENSTONE LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-2350ETHOSUXIMIDE SOLUTION [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 4 package rows20250516_19c924c2-f558-4c78-9277-2d7e0df2f505.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251322ethosuximide 250 MG in 5 mL Oral SolutionPSN19c924c2-f558-4c78-9277-2d7e0df2f50516
251322ethosuximide 50 MG/ML Oral SolutionSCD19c924c2-f558-4c78-9277-2d7e0df2f50516
251322ethosuximide 250 MG per 5 ML Oral SolutionSY19c924c2-f558-4c78-9277-2d7e0df2f50516

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-2350-7597622350071 BOTTLE, PLASTIC in 1 CARTON (59762-2350-7) / 474 mL in 1 BOTTLE, PLASTIC2022-07-010000-00-00NoNoCurrent