ETHOSUXIMIDE

Product NDC: 71335-1763
Requested package NDC: 71335-1763-1
11-digit product format: 713351763
Labeler code: 71335
Product ID: 71335-1763_e7ddb61f-bc96-4106-ba63-111fd1773425
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ETHOSUXIMIDE
Dosage form: CAPSULE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA211928
Marketing category: ANDA
Marketing start: 2019-05-15
Marketing end: 0000-00-00
Substance: ETHOSUXIMIDE
Active strength: 250 mg/1
Pharmacologic classes: Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	71335-1763	71335-1763-1	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
A211928-001	ETHOSUXIMIDE	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB		2019-02-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211928-001	AB

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	A211928-001	ETHOSUXIMIDE	250MG	CAPSULE / ORAL	AB		2019-02-19	`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	A211928-001	AB	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ETHOSUXIMIDE	ETHOSUXIMIDE	Strides Pharma Science Limited	a4dbc665-4db1-4d0a-9630-5cd200ec4c82	2026-06-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211928 application number: ANDA211928

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
71335-1763-1	71335176301	90 CAPSULE in 1 BOTTLE (71335-1763-1)	90 capsule	2021-01-06	0000-00-00	No	No	Current