Ethosuximide

Product NDC: 61748-024
Requested package NDC: 61748-024-16
11-digit product format: 617480024
Labeler code: 61748
Product ID: 61748-024_fc97e367-f4f2-400d-8033-7f114fc03998
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Ethosuximide
Dosage form: SOLUTION
Route: ORAL
Labeler: Versapharm Incorporated
Application: ANDA040506
Marketing category: ANDA
Marketing start: 2004-01-01
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	61748-024	61748-024-16	D	Discontinued by firm		2026-07-31

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A040506-001	ETHOSUXIMIDE	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA		2003-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040506-001	AA

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040506-001	ETHOSUXIMIDE	250MG/5ML	SYRUP / ORAL	AA		2003-12-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040506-001	AA	1	`a50c72e98297…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ethosuximide	ETHOSUXIMIDE	Chartwell Governmental & Specialty RX, LLC.	a825265d-ace9-4463-a16d-f6d5e1e31188	2026-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040506 application number: ANDA040506
Ethosuximide	ETHOSUXIMIDE	Chartwell RX, LLC	9812840a-004d-46fa-8414-7d04a384e06a	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040506 application number: ANDA040506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61748-024-16	ML - Milliliter	61748-024	e5e6a5c1-bf91-4bbd-b262-c0c89395a033	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ETHOSUXIMIDE	ACTIVE INGREDIENT	5SEH9X1D1D	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
ETHOSUXIMIDE	ACTIVE MOIETY	5SEH9X1D1D	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
ETHYL MALTOL	INACTIVE INGREDIENT	L6Q8K29L05	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
RASPBERRY	INACTIVE INGREDIENT	4N14V5R27W	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
SACCHARIN SODIUM ANHYDROUS	INACTIVE INGREDIENT	I4807BK602	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
SUCROSE	INACTIVE INGREDIENT	C151H8M554	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ETHOSUXIMIDE SOLUTION [VERSAPHARM INCORPORATED]	2

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5SEH9X1D1D	ETHOSUXIMIDE	77-67-8	ETHOSUXIMIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61748-024-16	61748002416	473 mL in 1 BOTTLE, PLASTIC (61748-024-16)	473 ml	2004-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ETHOSUXIMIDE ORAL SOLUTION, USP 250 mg/5 mL	Versapharm Incorporated \| Akorn Operating Company LLC \| Mikart, Inc.	2020-10-08	HUMAN PRESCRIPTION DRUG LABEL	4