Diacomit

Product NDC: 68418-7940
Requested package NDC: 68418-7940-6
11-digit product format: 684187940
Labeler code: 68418
Product ID: 68418-7940_7c968964-991e-4ec2-bc03-ef062b5bb0f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: stiripentol
Dosage form: CAPSULE
Route: ORAL
Labeler: BIOCODEX, INC.
Application: NDA206709
Marketing category: NDA
Marketing start: 2018-08-21
Substance: STIRIPENTOL
Active strength: 500 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 3 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Archive	Snapshot	Source SHA-256
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68418-7940	68418-7940-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68418-7940	68418-7940-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68418-7940	68418-7940-6	I	Inactivated by FDA	excluded / ndc_excluded.zip	`1332a3947898…`	`d4bfe170f9cd…`

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
N206709-001	DIACOMIT	STIRIPENTOL	250MG	CAPSULE / ORAL		RLD	2018-08-20
N206709-002	DIACOMIT	STIRIPENTOL	500MG	CAPSULE / ORAL		RLD, RS	2018-08-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N206709-001	ODE-403	2029-07-14
N206709-002	ODE-403	2029-07-14

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206709-001	DIACOMIT	250MG	CAPSULE / ORAL	RLD	2018-08-20	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206709-002	DIACOMIT	500MG	CAPSULE / ORAL	RLD, RS	2018-08-20	`782e0a99824c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 216 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206709-001	ODE-403	2029-07-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206709-002	ODE-403	2029-07-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	M-281	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	ODE-198	2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-001	ODE-403	2029-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	M-281	2025-07-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	ODE-198	2025-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206709-002	ODE-403	2029-07-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206709-001	M-281	2025-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-001	ODE-198	2025-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-001	ODE-403	2029-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	M-281	2025-07-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	ODE-198	2025-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206709-002	ODE-403	2029-07-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	M-281	2025-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	ODE-198	2025-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-001	ODE-403	2029-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	M-281	2025-07-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	ODE-198	2025-08-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206709-002	ODE-403	2029-07-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	M-281	2025-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	ODE-198	2025-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-001	ODE-403	2029-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	M-281	2025-07-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	ODE-198	2025-08-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206709-002	ODE-403	2029-07-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	M-281	2025-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	ODE-198	2025-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-001	ODE-403	2029-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	M-281	2025-07-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	ODE-198	2025-08-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206709-002	ODE-403	2029-07-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	M-281	2025-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	ODE-198	2025-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-001	ODE-403	2029-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	M-281	2025-07-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	ODE-198	2025-08-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206709-002	ODE-403	2029-07-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-001	M-281	2025-07-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206709-001	ODE-198	2025-08-20	`5bbf6a4d5a75…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
STIRIPENTOL	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
R02XOT8V8I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2054973	Internal RxNorm lookup
2054979	Internal RxNorm lookup
2054981	Internal RxNorm lookup
2054983	Internal RxNorm lookup
2055011	Internal RxNorm lookup
2055014	Internal RxNorm lookup
2055015	Internal RxNorm lookup
2055016	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
58304ba8-9779-4658-811e-94ffe08c3f16	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b726dffa-7bfc-4c08-889d-a3080b224d14	Product name	1	20181127

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68418-7940-6	2024-06-04	C162847	48780-1	1030e365-0d7f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DIACOMIT safely and effectively. See full prescribing information for DIACOMIT. DIACOMIT (stiripentol) capsules, for oral use DIACOMIT (stiripentol) for oral suspension Initial U.S. Approval: 2018
68418-7940-6	2024-01-30	C162847	48780-1	1030e365-0d7f-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use DIACOMIT safely and effectively. See full prescribing information for DIACOMIT. DIACOMIT (stiripentol) capsules, for oral use DIACOMIT (stiripentol) for oral suspension Initial U.S. Approval: 2018

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68418-7940-6	Diacomit	60 in 1 BOTTLE	CAPSULE	60		8
68418-7940-6	Diacomit	1 in 1 CARTON	CAPSULE	1		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68418-7940-6	EA - Each	68418-7940	485929b3-0de5-4051-b902-0e0d298d9fd8	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68418-7940	DIACOMIT (STIRIPENTOL) CAPSULE DIACOMIT (STIRIPENTOL) POWDER, FOR SUSPENSION [BIOCODEX, INC.]	7	Current NDC, Legacy NDC, 2 package rows	20240608_58304ba8-9779-4658-811e-94ffe08c3f16.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
Diacomit	STIRIPENTOL	BIOCODEX, INC.	58304ba8-9779-4658-811e-94ffe08c3f16	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206709 application number: NDA206709 ndc (package): 68418-7940-6 ndc (product): 68418-7940 ndc11 (package): 68418794006

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
R02XOT8V8I	STIRIPENTOL	137767-55-6	STIRIPENTOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2054979	DIACOMIT 250 MG Oral Capsule	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055016	DIACOMIT 250 MG Powder for Oral Suspension	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054983	DIACOMIT 500 MG Oral Capsule	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055014	DIACOMIT 500 MG Powder for Oral Suspension	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054973	stiripentol 250 MG Oral Capsule	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055015	stiripentol 250 MG Powder for Oral Suspension	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054981	stiripentol 500 MG Oral Capsule	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055011	stiripentol 500 MG Powder for Oral Suspension	PSN	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054979	stiripentol 250 MG Oral Capsule [Diacomit]	SBD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055016	stiripentol 250 MG Powder for Oral Suspension [Diacomit]	SBD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054983	stiripentol 500 MG Oral Capsule [Diacomit]	SBD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055014	stiripentol 500 MG Powder for Oral Suspension [Diacomit]	SBD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054973	stiripentol 250 MG Oral Capsule	SCD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055015	stiripentol 250 MG Powder for Oral Suspension	SCD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054981	stiripentol 500 MG Oral Capsule	SCD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055011	stiripentol 500 MG Powder for Oral Suspension	SCD	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054979	Diacomit 250 MG Oral Capsule	SY	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055016	Diacomit 250 MG Powder for Oral Suspension	SY	58304ba8-9779-4658-811e-94ffe08c3f16	8
2054983	Diacomit 500 MG Oral Capsule	SY	58304ba8-9779-4658-811e-94ffe08c3f16	8
2055014	Diacomit 500 MG Powder for Oral Suspension	SY	58304ba8-9779-4658-811e-94ffe08c3f16	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68418-7940-6	68418794006	1 BOTTLE in 1 CARTON (68418-7940-6) / 60 CAPSULE in 1 BOTTLE	1 bottle	2018-08-21	0000-00-00	No	No	Current