FDA.reportPublic FDA data

Celontin

Product NDC
24822-525
11-digit product format
248220525
Labeler code
24822
Product ID
24822-525_abac6b2e-bcd8-29c2-e053-2a95a90a2239
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
METHSUXIMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Farmea
Application
NDA010596
Marketing category
NDA
Marketing start
1999-01-01
Marketing end
0000-00-00
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
2021-12-31
Current FDA listing
Historical FDA.report record

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010596-007CELONTINMETHSUXIMIDE150MGCAPSULE / ORALRLD, Approved before 1982
N010596-008CELONTINMETHSUXIMIDE300MGCAPSULE / ORALABRLD, 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
N010596-008AB

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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19828072bd15b7f6…
2024-05-31 18:47 UTC2024-05N010596-008CELONTIN300MGCAPSULE / ORALABRLD, RS, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19825c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N010596-008CELONTIN300MGCAPSULE / ORALRLD, RS, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19825d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N010596-008CELONTIN300MGCAPSULE / ORALRLD, RS, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 19824b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N010596-008CELONTIN300MGCAPSULE / ORALRLD, RS, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 198274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N010596-008CELONTIN300MGCAPSULE / ORALRLD, RS, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N010596-008CELONTIN300MGCAPSULE / ORALRLD, RS, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N010596-007CELONTIN150MGCAPSULE / ORALRLD, Approved before 1982782e0a99824c…
2021-12-28 21:50 UTC2021-12N010596-008CELONTIN300MGCAPSULE / ORALRLD, RS, Approved before 1982782e0a99824c…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N010596-008AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N010596-008AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N010596-008AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N010596-008AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N010596-008AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N010596-008AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N010596-008AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N010596-008AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N010596-008AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N010596-008AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N010596-008AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N010596-008AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N010596-008AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N010596-008AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N010596-008AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N010596-008AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N010596-008AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N010596-008AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N010596-008AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N010596-008AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N010596-008AB13f0d92c62455…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010596-008AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CelontinMETHSUXIMIDEParke-Davis Div of Pfizer Inc64a6ee88-c6b1-4e13-8208-b6772ef65a742026-04-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 010596
application number: NDA010596