FDA.reportPublic FDA data

ETHOSUXIMIDE

Product NDC
0121-0670
11-digit product format
001210670
Labeler code
0121
Product ID
0121-0670_14d8b71e-abd8-49d4-b4cc-82880e54db8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ETHOSUXIMIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
ANDA040253
Marketing category
ANDA
Marketing start
2000-11-22
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
A040253-001ETHOSUXIMIDEETHOSUXIMIDE250MG/5MLSYRUP / ORALAA2000-11-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040253-001AA

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 22:54:322026-06A040253-001ETHOSUXIMIDE250MG/5MLSYRUP / ORALAA2000-11-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040253-001AA1a50c72e98297…

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 33 · 654 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
unii: PDC6A3C0OX
EthosuximideETHOSUXIMIDEMylan Pharmaceuticals Inc.19c924c2-f558-4c78-9277-2d7e0df2f5052026-07-24Warnings, Adverse reactionsExact identifier
application number: ANDA080258
ndc (package): 59762-2350-6
ndc (package): 59762-2350-7
ndc (product): 59762-2350
rxcui: 251322
spl id: 04f63742-92af-4b78-a7a6-f9f2f1c269e7
spl set id: 19c924c2-f558-4c78-9277-2d7e0df2f505
unii: 5SEH9X1D1D
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: PDC6A3C0OX
XenletaLEFAMULIN ACETATEMeitheal Pharmaceuticals Inc.eb972ea8-7502-422e-84bb-66cb8e93ca062026-07-22Warnings, Adverse reactionsExact identifier
unii: XF417D3PSL
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: PDC6A3C0OX
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552d9018-cc7d-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: PDC6A3C0OX
GlycerinGLYCERINBeijing Jingfeng Pharmaceutical (Shandong) Co., Ltd552e16b9-f46a-7838-e063-6394a90ab8aa2026-06-26WarningsExact identifier
unii: PDC6A3C0OX
ETHOSUXIMIDEETHOSUXIMIDEStrides Pharma Science Limiteda4dbc665-4db1-4d0a-9630-5cd200ec4c822026-06-25Warnings, Adverse reactionsExact identifier
application number: ANDA211928
ndc (package): 64380-878-06
ndc (product): 64380-878
rxcui: 197682
spl id: 55122228-722f-dcba-e063-6394a90ab78a
spl set id: a4dbc665-4db1-4d0a-9630-5cd200ec4c82
unii: 5SEH9X1D1D
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, BOVISTA, CARBO VEGETABILIS, CARBONEUM SULPHURATUM, COFFEA CRUDA, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, SULPHUR, ACETYLSALICYLICUM ACIDUM, FORMALINUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, TEREBINTHINA, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM,Energique, Inc.2e361b50-9268-4053-b13c-93af645498482026-06-25WarningsExact identifier
unii: PDC6A3C0OX
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R

Additional Listing Data#

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

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
8a5cc930-0b36-48a8-9ad0-de633b208742Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dcc989c7-4ccb-d599-44b3-233abc5285bbProduct name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0670-16ETHOSUXIMIDE473 mL in 1 BOTTLESOLUTION47317

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0670-16ML - Milliliter0121-0670d6633b2a-b95d-437d-8b2d-e322f70ab8b512014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ETHOSUXIMIDEACTIVE INGREDIENT5SEH9X1D1DETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
ETHOSUXIMIDEACTIVE MOIETY5SEH9X1D1DETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
SUCROSEINACTIVE INGREDIENTC151H8M554ETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RETHOSUXIMIDE SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0670ETHOSUXIMIDE SOLUTION [PAI HOLDINGS, LLC DBA PAI PHARMA]16Current NDC, Legacy NDC, 1 package rows20250326_8a5cc930-0b36-48a8-9ad0-de633b208742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
251322ethosuximide 250 MG in 5 mL Oral SolutionPSN8a5cc930-0b36-48a8-9ad0-de633b20874217
251322ethosuximide 50 MG/ML Oral SolutionSCD8a5cc930-0b36-48a8-9ad0-de633b20874217
251322ethosuximide 250 MG per 5 ML Oral SolutionSY8a5cc930-0b36-48a8-9ad0-de633b20874217

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0670-1600121067016473 mL in 1 BOTTLE (0121-0670-16) 473 ml2000-11-220000-00-00NoNoCurrent