Celontin

Product NDC: 0071-0525
11-digit product format: 000710525
Labeler code: 0071
Product ID: 0071-0525_5d3eee75-8d10-4969-b883-81b1d5d3ae97
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: methsuximide
Dosage form: CAPSULE
Route: ORAL
Labeler: Parke-Davis Div of Pfizer Inc
Application: NDA010596
Marketing category: NDA
Marketing start: 1957-02-08
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: 2027-12-31
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N010596-007	CELONTIN	METHSUXIMIDE	150MG	CAPSULE / ORAL		RLD, Approved before 1982
N010596-008	CELONTIN	METHSUXIMIDE	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N010596-008	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.

Product history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N010596-008	CELONTIN	300MG	CAPSULE / ORAL	AB	RLD, RS, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010596-008	CELONTIN	300MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N010596-008	CELONTIN	300MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N010596-008	CELONTIN	300MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N010596-008	CELONTIN	300MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N010596-008	CELONTIN	300MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010596-007	CELONTIN	150MG	CAPSULE / ORAL		RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N010596-008	CELONTIN	300MG	CAPSULE / ORAL		RLD, RS, Approved before 1982	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N010596-008	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010596-008	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010596-008	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010596-008	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010596-008	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010596-008	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010596-008	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010596-008	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010596-008	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010596-008	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010596-008	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010596-008	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010596-008	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010596-008	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010596-008	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N010596-008	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N010596-008	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010596-008	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010596-008	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010596-008	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010596-008	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N010596-008	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHSUXIMIDE	300 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0G76K8X6C0	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197949	Internal RxNorm lookup
207088	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
64a6ee88-c6b1-4e13-8208-b6772ef65a74	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c66d0cbc-4684-658d-2453-91fa387ed8ca	Product name	2	20240508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0071-0525-24	Celontin	100 in 1 BOTTLE	CAPSULE	100		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0071-0525-24	EA - Each	0071-0525	958f6ef1-baf3-4c6a-bd46-1bed6a0f9b74	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
METHSUXIMIDE	ACTIVE INGREDIENT	0G76K8X6C0	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
METHSUXIMIDE	ACTIVE MOIETY	0G76K8X6C0	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
GELATIN	INACTIVE INGREDIENT	2G86QN327L	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0071-0525	CELONTIN (METHSUXIMIDE) CAPSULE [PARKE-DAVIS DIV OF PFIZER INC]	15	Current NDC, Legacy NDC, 1 package rows	20250130_64a6ee88-c6b1-4e13-8208-b6772ef65a74.zip

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celontin	METHSUXIMIDE	Parke-Davis Div of Pfizer Inc	64a6ee88-c6b1-4e13-8208-b6772ef65a74	2026-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 010596 application number: NDA010596 ndc (product): 0071-0525

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0G76K8X6C0	METHSUXIMIDE	77-41-8	METHSUXIMIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
207088	Celontin 300 MG Oral Capsule	PSN	64a6ee88-c6b1-4e13-8208-b6772ef65a74	16
197949	methsuximide 300 MG Oral Capsule	PSN	64a6ee88-c6b1-4e13-8208-b6772ef65a74	16
207088	methsuximide 300 MG Oral Capsule [Celontin]	SBD	64a6ee88-c6b1-4e13-8208-b6772ef65a74	16
197949	methsuximide 300 MG Oral Capsule	SCD	64a6ee88-c6b1-4e13-8208-b6772ef65a74	16
207088	Celontin 300 MG Oral Capsule	SY	64a6ee88-c6b1-4e13-8208-b6772ef65a74	16

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0071-0525-24	00071052524	100 CAPSULE in 1 BOTTLE (0071-0525-24)	100 capsule	1957-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Celontin ® (Methsuximide Capsules, USP)	Parke-Davis Div of Pfizer Inc \| Pharmacia & Upjohn Company LLC \| Pfizer Manufacturing Deutschland GmbH	2026-04-07	HUMAN PRESCRIPTION DRUG LABEL	16